| Tai'ai (telitacicept) / Rongchang Pharma |
ChiCTR2200055179: Clinical study on the efficacy and safety of tatacept in the treatment of idiopathic membranous nephropathy |
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| Recruiting | 4 | 30 | | Telitacicept | Qilu Hospital of Shandong University; Qilu Hospital of Shandong University, Corporate Partial Funding | Membranous nephropathy | | | | |
ChiCTR2100051890: Efficacy and safety analysis of Tetrasip in refractory primary immune thrombocytopenia |
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| Not yet recruiting | 4 | 60 | | Telitacicept ;Eltrombopag ;Rituximab | The Second Affiliated Hospital of Kunming Medical University; The Second Affiliated Hospital of Kunming Medical University, Regional Science Foundation Project | Primary Immune Thrombocytopenia | | | | |
ChiCTR2400086874: A clinical study on the effect of Telitacicept on lymphocyte subsets in the treatment of moderate to severe active systemic lupus erythematosus |
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| Completed | 4 | 20 | | Conventional treatment+Telitacicept | The First Affiliated Hospital of Wenzhou Medical University; The FIrst Affiliated Hospital of Wenzhou Medical University, Self-financing | Systemic lupus erythematosus | | | | |
| Not yet recruiting | 4 | 90 | | Telitacicept combined with standard therapy; standard therapy | The First Hospital of China Medical University; The First Hospital of China Medical University, National Key Research and Development Program (2021YFC2501303) | Systemic Lupus Erythematosus (SLE) | | | | |
NCT05666336: Multi-omics Studies on the Efficacy of Telitacicept in Chinese SLE Patients |
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| Recruiting | 4 | 30 | RoW | Telitacicept, RC18, Hydroxychloroquine, HCQ, Prednisone, PRED, Methylprednisolone, MP, Cyclophosphamide, CTX, Mycophenolate Mofetil, MMF, Tacrolimus, TAC | Fen Li | Systemic Lupus Erythematosus | 06/24 | 06/24 | | |
ChiCTR2200064790: Efficacy and Safety of Telitacicept in Patients with IgA Nephropathy with Unsatisfactory Response to Traditional Therapy |
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| Not yet recruiting | 4 | 50 | | Telitacicept ;traditional therapy | Shandong Provincial Hospital; Shandong Provincial Hospital, Corporate Partial Funding | IgA Nephropathy | | | | |
ChiCTR2200058379: A randomized controlled study of Telitacicept in reducing relapse in patients with systemic lupus erythematosus (SLE) of low disease activity |
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| Not yet recruiting | 4 | 142 | | telitacicept +standard treatment ;standard treatment | Ruijin Hospital of Shanghai Jiao Tong University; Ruijin Hospital, Funded | SLE | | | | |
ChiCTR2200064438: The Underlying Effects of Gut Microbiome on Systemic Lupus Erythematosus Paitents with Telitacicept |
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| Not yet recruiting | 4 | 45 | | Injection of Telitacicept ;Conventional therapy | Xuzhou NO.1 People's Hospital; Xuzhou NO.1 People's Hospital, Rongchang Biopharmaceutical (Yantai) Co., Ltd. | Systemic Lupus Erythematosus | | | | |
NCT06546540: The Safety and Efficacy of Telitacicept in the Treatment of Systemic Sclerosis |
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| Recruiting | 4 | 20 | RoW | Telitacicept | Peking University Third Hospital | Systemic Sclerosis | 12/25 | 03/26 | | |
ChiCTR2400085742: Efficacy and safety of telitacicept for patients with systemic sclerosis in clinical practice: a single-center, single-arm, open-label study |
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| Completed | 4 | 8 | | Add telitacicept(160mg qw ih) to patients with the stable background immunosuppressive therapy | Ningbo Medical Center Lihuili Hospital; Ningbo Medical Center Lihuili Hospital, Bethune Puai Medical Research Fund | Systemic sclerosis | | | | |
NCT06677801: Immune Cell Subsets in SLE Patients Treated with Telitacicept |
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| Active, not recruiting | 4 | 50 | RoW | Telitacicept 160mg | Second Affiliated Hospital, School of Medicine, Zhejiang University | Systemic Lupus Erythematosus (SLE) | 10/26 | 10/27 | | |
NCT06723548: Telitacicept and Low-dose Steroids in Refractory Myasthenia Gravis |
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| Not yet recruiting | 4 | 30 | NA | Telitacicept, Pyridostigmine Bromide, NSISTs, prednisone | First Affiliated Hospital of Wenzhou Medical University | Myasthenia Gravis, Autoimmune Diseases | 12/25 | 12/26 | | |
NCT05899907: Efficacy and Safety of Telitacicept in Early SLE |
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| Recruiting | 4 | 180 | RoW | Telitacicept, RC18, Standard of Care | Peking Union Medical College Hospital, RemeGen Co., Ltd. | Lupus Erythematosus, Systemic | 03/25 | 09/25 | | |
ChiCTR2200063739: The efficacy and safety of telitacicept and belimumab in active lupus nephritis in the real world: a prospective cohort study |
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| Not yet recruiting | 4 | 60 | | ; | Nanjing Drum Tower Hospital; Nanjing Drum Tower Hospital, Rongchang Biopharmaceutical (Yantai) Co., Ltd. | lupus nephritis | | | | |
ChiCTR2400080182: Study on the Salvage Treatment of Chronic Antibody Mediated Rejection after Renal Transplantation with Telitacicept |
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| Not yet recruiting | 4 | 10 | | Telitacicept | Xiangya Hospital of Central South University; Xiangya Hospital of Central South University, corporate funding | cAMR | | | | |
NCT05965284: Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis (TTCAZAREM) |
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| Recruiting | 4 | 40 | RoW | Azathioprine, Telitacicept, Taiai for commercial name | Chinese SLE Treatment And Research Group | ANCA-associated Vasculitis, Maintenance Therapy | 12/25 | 12/26 | | |
ChiCTR2300070348: Study on the therapeutic efficacy and safety of Telitacicept in the treatment of relapsed and refractory inflammatory myopathy |
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| Not yet recruiting | 4 | 60 | | Telitacicept ;Placebo | Peking Union Medical College Hospital; Peking Union Medical College Hospital, Central government special program supporting high-level hospital for clinical research in Peking Union Medical College Hospital (2022-PUMCH-A-107) | inflammatory myopathy | | | | |
ChiCTR2300076949: Efficacy and safety of recombinant human B lymphocyte stimulating factor receptor-antibody fusion protein for injection in IgA nephropathy patients |
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| Not yet recruiting | 4 | 40 | | Telitacicept+prednisone; prednisone | Xijing Hospital; Xijing Hospital, This study was supported by the Key Project of Shaanxi Province (2022ZDLSF03-12), Project of Xijing Hospital (2022XJZT-YH08), and National Natural Science Foundation of China (Nos 81470993 and 81272621). | IgAN | | | | |
ChiCTR2400084654: Efficacy and safety of Telitacicept in the treatment of recurrent IgA nephropathy after transplantation |
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| Not yet recruiting | 4 | 40 | | Conventional treatment+Taetaxel; Conventional treatment | Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology; Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, RemeGen Co. Ltd. | recurrent IgA nephropathy after transplantation | | | | |
ChiCTR2300074080: Efficacy and safety of telitacicept in the treatment of refractory systemic lupus erythematosus with thrombocytopenia in patients with poor efficacy of hormone combined with calcineurin inhibitors |
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| Not yet recruiting | 4 | 50 | | Tagitacept in combination with glucocorticoids and calcineurin inhibitors | The First Affiliated Hospital of Nanjing Medical University; The First Affiliated Hospital of Nanjing Medical University, Remegen Co.,Ltd | Systemic lupus erythematosus | | | | |
NCT05962840: Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis (TTCAAVREM) |
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| Recruiting | 4 | 40 | RoW | Telitacicept, Taiai for commercial name, Placebo of Telitacicept | Chinese SLE Treatment And Research Group, Peking Union Medical College Hospital | ANCA Associated Vasculitis | 12/26 | 12/26 | | |
ChiCTR2400090264: The Efficacy and Safety of Head-to-Head Treatment with Telitacicept and Belimumab for Lupus Nephritis: A Multicenter Real-World Study |
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| Not yet recruiting | 4 | 130 | | None; None | The First Affiliated Hospital of Guangxi Medical University; The First Affiliated Hospital of Guangxi Medical University, The First Affiliated Hospital of Guangxi Medical University | lupus nephritis | | | | |
NCT04082416: Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) |
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| Completed | 3 | 335 | RoW | Placebo plus standard therapy, Standard therapy, RC18 160 mg plus standard therapy | RemeGen Co., Ltd. | Systemic Lupus Erythematosus | 04/22 | 06/22 | | |
NCT03016013: A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects with Inadequate Response to MTX Due to Treat Moderate and Severe Rheumatoid Arthritis. |
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| Completed | 3 | 479 | RoW | Placebo plus MTX, MTX=Methotrexate, RC18 160 mg plus MTX, RC18 | RemeGen Co., Ltd. | Moderate and Severe RheumatoId Arthritis | 11/22 | 12/22 | | |
NCT03330418: A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders |
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| Recruiting | 3 | 166 | RoW | Placebo, RC18 160 mg | RemeGen Co., Ltd. | Neuromyelitis Optica Spectrum Disorders | 05/25 | 12/25 | | |
NCT06456580: A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (RemeMG) |
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| Recruiting | 3 | 180 | US | Telitacicept, RC18, RC18-L, Placebo | RemeGen Co., Ltd. | Generalized Myasthenia Gravis | 07/26 | 10/27 | | |
NCT06456567: A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-2) |
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| Recruiting | 3 | 350 | US | Telitacicept, Placebo | RemeGen Co., Ltd. | Systemic Lupus Erythematosus | 04/27 | 05/27 | | |
NCT05306574: A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1) |
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| Recruiting | 3 | 341 | Europe, US, RoW | Telitacicept, RC18, Placebo | RemeGen Co., Ltd. | Systemic Lupus Erythematosus | 06/25 | 09/25 | | |
NCT05339217: Efficacy and Immunological Evaluation of Telitacicept and Low Dose IL2 in the Treatment of Systemic Lupus Erythematosus |
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| Recruiting | 3 | 60 | RoW | Telitacicept, RC-18, Interleukin-2, Recombinant Human interleukine-2 | Liu Tian | Systemic Lupus Erythematosus | 07/25 | 07/25 | | |
NCT05799287: A Study of Telitacicept in Patients with Primary Immunoglobulin A（IgA） Nephropathy |
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| Active, not recruiting | 3 | 318 | RoW | Telitacicept, RC18, Placebo | RemeGen Co., Ltd. | Primary IgA Nephropathy | 10/25 | 12/25 | | |
STERN, NCT06125405: Study of the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome |
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| Recruiting | 3 | 20 | RoW | Telitacicept | The Children's Hospital of Zhejiang University School of Medicine | Nephrotic Syndrome in Children, Telitacicept | 10/26 | 10/27 | | |
NCT05737160: Study of Telitacicept in Generalized Myasthenia Gravis |
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| Recruiting | 3 | 100 | RoW | Telitacicept, RC18, Placebo | RemeGen Co., Ltd. | Myasthenia Gravis, Generalized | 12/26 | 05/27 | | |
NCT05673993: A Study to Evaluate the Efficacy and Safety of Telitacicept in Subjects With Active Primary Sjogren's Syndrome |
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| Active, not recruiting | 3 | 381 | RoW | Telitacicept 80 mg, RC 18 80 mg, Telitacicept 160 mg, RC 18 160 mg, Placebo | RemeGen Co., Ltd. | Primary Sjogren's Syndrome | 12/27 | 06/28 | | |
NCT05596708: Study of Telitacicept in Patients With Refractory IgA Nephropathy |
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| Not yet recruiting | 2/3 | 40 | RoW | Telitacicept | Second Affiliated Hospital, School of Medicine, Zhejiang University | IgA Nephropathy | 06/25 | 09/26 | | |
NCT04302103: A Study of TACI（Transmembrane Activator and Calcium-modulator and Cyclophilin Ligand (CAML) Interactor）-Antibody Fusion Protein Injection (RC18) in Subjects With Systemic Myasthenia Gravis |
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| Completed | 2 | 29 | RoW | RC18 160mg, RC18 240 mg | RemeGen Co., Ltd. | Systemic Myasthenia Gravis | 01/22 | 02/22 | | |
| Recruiting | 2 | 20 | RoW | Telitacicept, traditional antithrombotic and immunosuppressive treatment | Peking Union Medical College Hospital | Anti Phospholipid Syndrome | 07/22 | 12/22 | | |
NCT06315530: Effect of Telitacicept on Antibody Titers in Primary APS Patients |
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| Recruiting | 2 | 20 | RoW | Telitacicept, SOC | Ruijin Hospital | Antiphospholipid Syndrome (APS) | 12/25 | 12/26 | | |
NCT04905212: A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy |
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| Terminated | 2 | 15 | US | Telitacicept 160mg, Telitacicept 240mg, Placebo | RemeGen Co., Ltd. | IgA Nephropathy | 11/23 | 11/23 | | |
NCT06375005: Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis |
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| Not yet recruiting | 2 | 38 | RoW | Telitacicept, Taiai for commercial name, Mycophenolate Mofetil, MMF | Second Affiliated Hospital, School of Medicine, Zhejiang University | Diffuse Cutaneous Systemic Sclerosis | 08/25 | 12/26 | | |
NCT05929248: Exploring the Therapeutic Effect of Telitacicept on Lupus Erythematosus Complicated With Thrombocytopenia |
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| Not yet recruiting | 2 | 64 | NA | Telitacicept, RC18, conventional therapy, Placebo | Guanmin Gao | Systemic Lupus Erythematosus | 06/24 | 12/24 | | |
NCT06510283: Efficacy and Safety of Taitacept in Treatment of Refractory or Recurrent Anti-NMDAR/Anti-LGI1 Encephalitis |
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| Recruiting | 2 | 10 | RoW | Taitacept | Beijing Tongren Hospital | Anti-N-Methyl-D-Aspartate Receptor Encephalitis | 07/27 | 07/28 | | |
| Not yet recruiting | 2 | 172 | RoW | Telitacicept, Prednisone, Cyclophosphamide | Renmin Hospital of Wuhan University | Primary Membranous Nephropathy | 10/26 | 10/27 | | |
| Recruiting | 2 | 120 | RoW | Telitacicept 240 mg, RC18 240 mg, Telitacicept 160 mg, RC18 160 mg, Placebo | RemeGen Co., Ltd. | Lupus Nephritis | 12/25 | 01/26 | | |
ChiCTR2400084781: A Study on the Efficacy and Safety of Sequential Efgartigimod and Telitacicept Therapy in the Treatment of Generalized Myasthenia Gravis |
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| Not yet recruiting | 2 | 30 | | The patients in the treatment group received a dose of 10mg/kg of eculizumab via intravenous infusion over 1 hour once a week for 4 consecutive weeks in the first month. Starting from the second month, they began receiving a subcutaneous injection of 240mg of Telitacicept acetate weekly, and continued long-term Telitacicept acetate treatment until the end of the 24-week study observation period. | Peking University People's Hospital; Peking University People's Hospital, The research was funded by the National Natural Science Foundation of China (Grant No. 81303013). | myasthenia gravis | | | | |
ChiCTR2400084715: A Study on the Efficacy and Safety of Telitacicept Treatment versus Tacrolimus Treatment in Newly Diagnosed AchR-Positive Generalized Myasthenia Gravis |
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| Not yet recruiting | 2 | 124 | | Subjects in the Tocilizumab group received a subcutaneous injection of 240mg weekly.; Subjects in the Tacrolimus group received oral treatment with a daily dose of 3mg of Tacrolimus. | Peking University People's Hospital; Peking University People's Hospital, The research was funded by the National Natural Science Foundation of China (81303013) | myasthenia gravis | | | | |
NCT04625153: RC18 in Patients With Relapsing Remitting Multiple Sclerosis：a Phase II Trial |
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| Recruiting | 2 | 30 | RoW | RC18 160mg, telitacicept, RC18 240mg | RemeGen Co., Ltd. | Multiple Sclerosis, Relapsing-Remitting | 10/25 | 12/25 | | |
NCT05998759: Telitacicept for the Treatment of Connective Tissue Disease-associated Thrombocytopenia |
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| Recruiting | 2 | 296 | RoW | Telitacicept, recombinant human B lymphocyte stimulating factor receptor-Fc fusion protein, Recombinant Human B Lymphocyte(RC18), Tai'ai®, Placebo, Placebo control, control | Beijing Hospital, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial), Peking University People's Hospital, Peking University Third Hospital, First Affiliated Hospital, Sun Yat-Sen University, Guangdong Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, Wuhan Union Hospital, China, Second Xiangya Hospital of Central South University, Xiangya Hospital of Central South University, The Affiliated Hospital of Inner Mongolia Medical University, First Hospital of China Medical University, Shandong Provincial Hospital, Changhai Hospital, RenJi Hospital, Shanxi Bethune Hospital, West China Hospital, Institute of Hematology & Blood Diseases Hospital, China, Tianjin First Central Hospital, Tianjin Medical University General Hospital, People's Hospital of Xinjiang Uygur Autonomous Region, The First People's Hospital of Yunnan | Connective Tissue Diseases, Thrombocytopenia | 12/25 | 12/25 | | |
ChiCTR2400083898: Population pharmacokinetic study of Telitacicept in children with lupus nephritis |
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| Not yet recruiting | 2 | 50 | | During the screening period, eligible subjects who met the inclusion criteria were administered the study drug at baseline (Day 0), 7, 14, 21, 28 days, and then weekly for a total treatment duration of 24 weeks. | Children’s Hospital of Fudan University; Children’s Hospital of Fudan University, Transverse research project of Children’s Hospital of Fudan University | pediatric lupus nephritis | | | | |
ChiCTR2400086459: Effect of Telitacicept on skin damage and related cytokine levels in patients with Systemic Lupus Erythematosus |
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| Recruiting | 2 | 50 | | Telitacicept 160 mg / time once a week subcutaneous injection therapy. | Department of Dermatology, Second Affiliated Hospital of Xi 'an Jiaotong University; Xi 'an Jiaotong University Second Affiliated Hospital, Enterprise scientific research funds | systemic lupus erythematosus | | | | |
TEST-T-AAGN, NCT06656962: The Efficacy and Safety of Treatment with Telitacicept in Antineutrophil Cytoplasmic Antibody-associated Nephritis (AAGN) |
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| Active, not recruiting | 1/2 | 15 | RoW | Telitacicept 160mg, Prednisone, Cyclophosphamide, Prednisone (and methylprednisolone) | Renmin Hospital of Wuhan University | Antineutrophil Cytoplasmic Antibody (ANCA)-associated Nephritis (AAGN) | 12/25 | 10/26 | | |
ChiCTR2400081474: A clinical study of Telitacicept combined with traditional regimens in refractory lupus nephritis in children |
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| Recruiting | 1/2 | 34 | | Telitacicept+ Standard treatment | Children's Hospital of Fudan University; Children's Hospital of Fudan University, Self-funded | Lupus nephritis | | | | |
NCT05247203: Telitacicept Study in Chinese Subjects With Systemic Lupus Erythematosus |
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| Completed | 1 | 92 | RoW | Telitacicept, RC18, standard therapy | RemeGen Co., Ltd. | Systemic Lupus Erythematosus | 10/23 | 11/23 | | |
NCT06549959: A Single Dose Study to Investigate the Pharmacokinetics (PK) of Telitacicept Pre-filled Injection and Freeze-dried Powder Injection in Chinese Healthy Subjects |
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| Recruiting | 1 | 248 | RoW | Telitacicept Pre-filled Injection 80mg, Telitacicept Freeze-dried powder Injection 80mg | RemeGen Co., Ltd. | Healthy | 11/24 | 12/24 | | |
NCT05687526: A Study of Telitacicept in Subjects With Childhood-onset Systemic Lupus Erythematosus |
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| Recruiting | 1 | 12 | RoW | Telitacicept, RC18 | RemeGen Co., Ltd. | Systemic Lupus Erythematosus | 09/25 | 10/25 | | |
ChiCTR2400086819: A comparative pharmacokinetic study of single subcutaneous injection of Telitacicept injection and Telitacicept for injection in healthy Chinese subjects |
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| Not yet recruiting | 1 | 248 | | The drug was administered subcutaneously to the front of the thigh. The eligible subjects were randomly assigned to receive a single subcutaneous injection of 80mg of Telitacicept in the Telitacicept For Injection group.; The drug was administered subcutaneously to the front of the thigh. The eligible subjects were randomly assigned to receive a single subcutaneous injection of 80mg of Telitacicept in the Telitacicept Injection group. | West China Hospital of Sichuan University; Remegen biopharmaceutical (Yantai) Co. , Ltd., Remegen biopharmaceutical (Yantai) Co. , Ltd. | Systemic lupus erythematosus | | | | |
ChiCTR2000036285: A Recombinant Human B Lymphocyte Stimulator Receptor-Immunoglobulin G (IgG ) Fc Fusion Protein in the Treatment of Subjects with Neuromyelitis Optica Spectrum Disorders: a Single Center, Randomized, Controlled Clinical Study |
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| Not yet recruiting | N/A | 60 | | plasma exchange and Telitacicept ;plasma exchange and placebo | Renji Hospital, School of Medicine, Shanghai Jiao Tong University; Level of the institution：, Shanghai Shenkang Hospital Development Center | Neuromyelitis Optica Spectrum Disorders | | | | |
NCT06137053: Effect of Telitacicept on Transitional Regulatory B Cells in Patients With Systemic Lupus Erythematosus |
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| Recruiting | N/A | 50 | RoW | | Yanfeng Hou | Telitacicept, Systemic Lupus Erythematosus, Therapy | 12/25 | 12/25 | | |
ChiCTR2300076828: The efficacy and safety of telitacicept in patients with lupus nephritis: a single-center, real-world retrospective study |
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| Completed | N/A | 58 | | None | Zhangzhou Municipal Hospital of Fujian; Zhangzhou Municipal Hospital of Fujian, Self-funded | Lupus nephritis | | | | |
ChiCTR2100043389: Prospective one-arm study of glucocorticoid combined with Telitacicept in the treatment of IgG4 related diseases |
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| Recruiting | N/A | 10 | | Telitacicept | Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology; Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Tongji Hospital Clinical Research Flagship Program | IgG4 related diseases | | | | |
ChiCTR2300068254: An exploratory study on the efficacy and safety of Telitacicept in the treatment of moderate and severe primary Sjogren's syndrome |
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| Not yet recruiting | N/A | 58 | | Telitacicept 80mg subcutaneous injection once a week for 12 weeks, a total of 12 times | The First Affiliated Hospital of China University of Science and Technology; The First Affiliated Hospital of China University of Science and Technology, Patients pay their own expenses and the company provides partial support | Primary Sjogren's syndrome | | | | |
NCT06458972: Safety, Efficacy, and Compliance of Telitacicept in the Treatment of Systemic Lupus Erythematosus (SLE) |
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| Recruiting | N/A | 139 | RoW | | Tongji Hospital, Jingzhou Central Hospital, Wuhan Central Hospital, Xiangyang Central Hospital, Wuhan No.1 Hospital, China Three Gorges University, Yichang, China, Zhongnan Hospital Affiliated to Wuhan University, The First People's Hospital of Jingzhou | Systemic Lupus Erythematosus | 10/24 | 12/24 | | |
ChiCTR2200060785: Efficacy and Safety of Telitacicept for induction and maintenance of remission in refractory and recurrent Antineutrophil Cytoplasmic Antibody-Associated Vasculitis: an exploratory study |
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| Not yet recruiting | N/A | 20 | | add telitacicept | The Second Affiliated Hospital of Nanchang University; The Second Affiliated Hospital of Nanchang University, Rongchang Biopharmaceutical (Yantai) Co., Ltd. | Antineutrophil Cytoplasmic Antibody-Associated Vasculitis | | | | |
NCT06394063: Efficacy and Safety of Telitacicept for Prevention of Flares in SLE Patients |
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| Recruiting | N/A | 176 | RoW | Telitacicept, Placebo | RenJi Hospital | Systemic Lupus Erythematosus | 06/27 | 06/27 | | |
| Not yet recruiting | N/A | 118 | RoW | Telitacicept 240mg, Glucocorticoid | Ruijin Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, RenJi Hospital, Sichuan Provincial People's Hospital, Renmin Hospital of Wuhan University, Shanghai 6th People's Hospital, Shanghai Longhua Hospital, Huashan Hospital, Shanghai Changzheng Hospital, Yijishan Hospital of Wannan Medical College, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Songjiang Hospital Affiliated to Shanghai Jiaotong University School of Medicine | IgA Nephropathy (IgAN), Kidney Diseases, Telitacicept, Glucocorticoid | 12/26 | 12/26 | | |
ChiCTR2400083794: A multicenter prospective randomized controlled study on the treatment of primary IgA nephropathy with recombinant human B lymphocyte stimulatory factor receptor antibody fusion protein (Telitacicept) |
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| Recruiting | N/A | 90 | | Based on the basic treatment, the patients were treated with Telitacicept L. Administration of Telitacicept subcutaneously at a dose of 240 mg once a week; Basic therapeutic drugs. In this study, ACEI/ARB drugs were used as basic drugs. | Ningxia Medical University General; Ningxia Medical University General, Remegen | IgAnephropathy | | | | |
ChiCTR2400079432: Telitacicept Exploratory study of sequential rituximab in the treatment of Sjogren's syndrome with severe thrombocytopenia |
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| Not yet recruiting | N/A | 12 | | Using Telitacicept | the First People's Hospital of qinzhou; the First People's Hospital of qinzhou, raise independently | Sjogren's syndrome combined with severe thrombocytopenia | | | | |
ChiCTR2400083991: Efficacy and safety of telitacicept in the treatment of primary IgA nephropathy: a prospective cohort study |
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| Not yet recruiting | N/A | 100 | | None; None | The Second Hospital of Shanxi Medical University; The Second Hospital of Shanxi Medical University, Self-financing | IgA nephropathy | | | | |
ChiCTR2300077036: A randomized, double-blind, multicenter, placebo-controlled study of the efficacy and safety of telitacicept in the treatment of primary membranous nephropathy |
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| Not yet recruiting | N/A | 60 | | Telitacicept; Placebo | Chinese PLA General Hospital; Chinese PLA General Hospital, self-financed | Primary Membranous Nephropathy | | | | |
ChiCTR2400084690: Exploring the efficacy, safty, and biomarkers in the treatment of Neuroimmune Diseases with Telitacicept (Tai Ai ®)- a Single Center, Open Label, Real World Study |
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| Not yet recruiting | N/A | 60 | | Telitacicept 160mg/240mg; Telitacicept 160mg/240mg; Telitacicept 160mg/240mg | Linyi People's Hospital; Linyi People's Hospital, China zhongguancun Precision Medicine science and technology foundation | Neuroimmune Diseases | | | | |
ChiCTR2300079107: A multicenter open one-arm clinical study of titacercept for injection in the treatment of active primary Sjogrens syndrome |
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| Not yet recruiting | N/A | 300 | | B-cell targeting biologics 160mg subcutaneous injection of Taitacept once a week 24 weeks | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, self-finance | primary desiccation syndrome | | | | |
ChiCTR2300075401: Exploring the efficacy and biomarkers in the treatment of myasthenia gravis with Telitacicept |
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| Not yet recruiting | N/A | 60 | | Telitacicept | Xiangya Hospital of Central South University; Xiangya Hospital of Central South University, self-financing | myasthenia gravis | | | | |
NCT05588830: The Efficacy and Safety of Telitacicept and Belimumab in Active Lupus Nephritis in the Real World: a Prospective Cohort Study |
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| Not yet recruiting | N/A | 60 | NA | Belimumab, Telitacicept | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Lupus Nephritis, Belimumab, Telitacicept | 10/23 | 03/24 | | |
NCT05644210: Telitacicept Followed With Rituximab Therapy on APS Secondary to SLE |
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| Recruiting | N/A | 80 | RoW | Telitacicept, TA, Rituximab, RTX, Aspirin, Asp, Warfarin, WF, Hydroxychloroquine, HCQ, Prednisone, Pred | Qilu Hospital of Shandong University | Antiphospholipid Syndrome | 12/25 | 12/25 | | |
| Aidixi (disitamab vedotin) / Pfizer |
| Active, not recruiting | 4 | 51 | RoW | Disitamab Vedotin Combined With Fruquintinib | Zhongnan Hospital, Huangshi Central Hospital, China, The First People's Hospital of Tianmen, Sir Run Run Shaw Hospital, Hubei Cancer Hospital | HER2, Colorectal Cancer | 01/25 | 12/25 | | |
NCT05723991: Study of Disitamab Vedotin Combined With Gemcitabine in Neoadjuvant Treatment of Urothelial Carcinoma |
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| Recruiting | 4 | 36 | RoW | Disitamab Vedotin and Gemcitabine | Chunguang yang (101937) | Radical Cystectomy, Urothelial Carcinoma | 09/24 | 09/25 | | |
NCT05861635: The Study of Vidicizumab Combined With Tirelizumab in the Treatment of Breast Cancer With Low HER2 Expression |
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| Recruiting | 4 | 42 | RoW | Disitamab Vedotin combined with Tislelizumab | Wuhan Union Hospital, China | Breast Cancer, Neoadjuvant Therapy | 02/25 | 02/26 | | |
NCT05488353: A Clinical Study of Disitamab Vedotin for Injection Combined With Penpulimab Injection in Neoadjuvant Therapy for Patients With HER2-expressing Cisplatin-intolerant cT2-T4aNxM0 Bladder Urothelial Carcinoma |
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| Not yet recruiting | 4 | 48 | NA | Disitamab Vedotin for Injection,Penpulimab Injection | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital of Southern Medical University, Southern Medical University, China, The Third Affiliated Hospital of Southern Medical University | Bladder Cancer | 04/26 | 04/26 | | |
ChiCTR2200063369: A clinical study of Disitamab Vedotin for Injection combined with Penpulimab Injection in neoadjuvant therapy for patients with HER2-expressing cisplatin-intolerant cT2-T4aNxM0 bladder urothelial carcinoma |
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| Not yet recruiting | 4 | 96 | | Disitamab Vedotin for injection ;Penpulimab injection | Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Sun Yat-sen Memorial Hospital, Sun Yat-sen University, corporate sponsorship/Rongchang Biopharmaceutical (Yantai) Co., Ltd. | cT2-T4aNxM0 bladder urothelial carcinoma | | | | |
ChiCTR2400084761: Distamab Vedotin combined with carboplatin and bevacizumab for HER2-expressing platinum-sensitive ovarian cancer with prior PARPi treatment: a single arm, phase II study. |
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| Not yet recruiting | 4 | 39 | | Distamab Vedotin combined with carboplatin and bevacizumab | Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center, RemeGen Co., Ltd. | ovarian cancer | | | | |
NCT04714190: A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression |
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| Recruiting | 3 | 351 | RoW | RC48-ADC, Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection, Paclitaxel injection, Taxol, Irinotecan Hydrochloride Injection, CAMPTO, Apatinib Mesylate Tablets, Aitan | RemeGen Co., Ltd. | Gastric Cancer, HER2 Overexpressing Gastric Carcinoma | 12/24 | 06/25 | | |
RC48-C012, NCT04400695: A Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2 |
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| Recruiting | 3 | 366 | RoW | RC48-ADC, RC48, Paclitaxel Injection, Taxol, Docetaxel Injection, Taxotere, Vinorelbine Tartrate Injection, Navelbine, Capecitabine Tablets, Xeloda | RemeGen Co., Ltd. | Breast Cancer | 06/24 | 12/24 | | |
NCT06278870: Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial |
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| Recruiting | 3 | 312 | RoW | disitamab vedotin, RC-48, Pyrotinib, trastuzumab, Pertuzumab, taxane drug | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | HER2-positive Metastatic Breast Cancer, First-line Treatment | 06/31 | 06/31 | | |
KEYNOTE-D74, NCT05911295: Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2 |
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| Recruiting | 3 | 700 | Europe, Canada, US, RoW | disitamab vedotin, RC48, RC48-ADC, pembrolizumab, KEYTRUDA®, gemcitabine, Gemzar, cisplatin, carboplatin | Seagen Inc., RemeGen Co., Ltd., Merck Sharp & Dohme LLC | Urothelial Carcinoma | 06/26 | 04/29 | | |
RC48-C016, NCT05302284: A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma |
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| Recruiting | 3 | 452 | RoW | RC48-ADC, Disitamab Vedotin, Toripalimab, JS001, Gemcitabine, Cisplatin, Carboplatin | RemeGen Co., Ltd. | Urothelial Carcinoma, HER2-expressing | 12/26 | 04/28 | | |
NCT05904964: Disitamab Vedotin (RC48) in Hormone Receptor Positive, HER2-low Metastatic Breast Cancer (the Rosy Trial) |
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| Recruiting | 3 | 288 | RoW | Disitamab vedotin, RC48, Endocrine therapy | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | HR Positive/HER2 Low Expression Metastatic Breast Cancer | 03/28 | 03/30 | | |
RC48-C006, NCT03500380: A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases |
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| Active, not recruiting | 2/3 | 301 | RoW | RC48-ADC, RC48, Lapatinib, Capecitabine | RemeGen Co., Ltd. | Breast Neoplasms, Breast Diseases, Capecitabine, HER2-positive Breast Cancer, HER2 Positive Breast Carcinoma, HER2-positive Advanced Breast With Liver Metastases | 07/24 | 12/24 | | |
NCT06221748: DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy |
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| Recruiting | 2/3 | 90 | RoW | Disitamab Vedotin Injection, DV,RC48, Cadonilimab Injection, AK104, Cadonilimab Injection, Paclitaxel Injection | RemeGen Co., Ltd. | Gastric Cancer, Gastroesophageal Junction Adenocarcinoma | 12/26 | 12/27 | | |
NCT05980481: A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer |
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| Recruiting | 2/3 | 130 | RoW | RC48-ADC, Disitamab Vedotin, Trastuzumab Injection, Trastuzumab, Toripalimab, JS001, Oxaliplatin injection, Oxaliplatin, Capecitabine, Capecitabine Tablets | RemeGen Co., Ltd. | Gastric Cancer | 07/24 | 07/25 | | |
CTR20230905: An open-label, single-arm, multicenter phase II clinical study to evaluate the efficacy and safety of intravenous vedisitumab for injection in combination with gemcitabine intravesical infusion in patients with high-risk non-muscle-invasive bladder cancer |
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| Ongoing | 2 | 86 | China | Aidixi (disitamab vedotin) - Rongchang Pharma, Pfizer, gemcitabine - Generic mfg. | Remegen Biopharmaceutical (Yantai) Co., Ltd | Non-responsive high-risk non-muscle-invasive bladder cancer (NMIBC) | | | | |
RC48-C024, CTR20231476: A randomized, open-label, multicenter phase II clinical study evaluating the efficacy and safety of vedicitumab alone or in combination with toripalimab or sequential chemotherapy in patients with HR-negative, HER2-low breast cancer |
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| Ongoing | 2 | | China | Aidixi (disitamab vedotin) - Rongchang Pharma, Pfizer, Loqtorzi (toripalimab) - Shanghai Junshi Biosci, Coherus Biosci, carboplatin - Generic mfg., epirubicin - Generic mfg., cyclophosphamide - Generic mfg. | Remegen Biopharmaceutical (Yantai) Co., Ltd | HR-negative, HER2-low breast cancer | | | | |
RC48-C026, CTR20232220: A randomized, open-label, multicenter phase II clinical study evaluating the efficacy and safety of vedicitumab versus pertuzumab with or without toripalimab in the neoadjuvant treatment of patients with HER2-positive breast cancer |
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| Ongoing | 2 | 80 | China | Aidixi (disitamab vedotin) - Rongchang Pharma, Pfizer, Loqtorzi (toripalimab) - Shanghai Junshi Biosci, Coherus Biosci, Perjeta (pertuzumab) - Roche | Remegen Biopharmaceutical (Yantai) Co., Ltd | HER2-positive breast cancer | | | | |
RC48-C022, CTR20233553: A phase II clinical study to evaluate the efficacy and safety of injectable vedicitumab plus toripalimab with or without chemotherapy (capecitabine + oxaliplatin) versus chemotherapy for the perioperative treatment of resectable locally advanced gastric/g |
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| Recruiting | 2 | 90 | China | Aidixi (disitamab vedotin) - Rongchang Pharma, Pfizer, Loqtorzi (toripalimab) - Shanghai Junshi Biosci, Coherus Biosci, capecitabine - Generic mfg., oxaliplatin - Generic mfg. | Remegen Biopharmaceutical (Yantai) Co., Ltd | HER2-expressing resectable locally advanced gastric/gastroesophageal junction adenocarcinoma | | | | |
RC48-C009, NCT03809013: A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer |
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| Completed | 2 | 64 | RoW | RC48-ADC, Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection | RemeGen Co., Ltd. | Urothelial Carcinoma | 03/21 | 06/23 | | |
NCT04073602: A Study of RC48-ADC in Subjects With HER2-negative Locally Advanced or Metastatic Urothelial Cancer |
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| Completed | 2 | 19 | RoW | RC48-ADC, Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection | RemeGen Co., Ltd. | Urothelial Carcinoma | 09/22 | 01/23 | | |
NCT05601401: Phase II Study of RC48-ADC in Treating Patients With Salivary Gland Tumors Expressing HER2 |
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| Recruiting | 2 | 10 | RoW | RC48-ADC, RC48 | Peking Union Medical College Hospital | Salivary Gland Tumors | 03/23 | 12/23 | | |
NCT06383533: Disitamab Vedotin Plus Cadonilimab in Patients With HER2 Mutant Advanced or Metastatic Bile Duct Adenocarcinoma |
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| Recruiting | 2 | 28 | RoW | Disitamab Vedotin Plus Cadonilimab | Zhejiang Cancer Hospital | Bile Duct Adenocarcinoma Non-Resectable, HER2 Gene Mutation | 05/25 | 12/25 | | |
NCT05241899: A Phase II Clinical Study of Fruquintinib Combined With RC48 in the Treatment of Previously Treated HER2-positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (G/GEJ) Cancer |
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| Not yet recruiting | 2 | 56 | RoW | Fruquintinib + RC48 | The First Affiliated Hospital of Zhengzhou University | Gastric Cancer | 05/23 | 05/25 | | |
| Recruiting | 2 | 120 | RoW | RC48-ADC, Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection | RemeGen Co., Ltd. | Gynecological Malignancy | 10/24 | 06/25 | | |
NCT05356351: An Open-label, Single-arm, Multicenter Phase II Clinical Study： Evaluating RC48-ADC Combined With Triplizumab in the Neoadjuvant Treatment of Her2-positive Muscle-invasive Bladder Cancer |
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| Not yet recruiting | 2 | 30 | NA | RC48- ADC, Triplizumab | Tianjin Medical University Cancer Institute and Hospital, Xiangya Hospital of Central South University, First Affiliated Hospital Xi'an Jiaotong University, The Southwest Hospital of AMU, Tongji Hospital, Chongqing University Cancer Hospital, Hunan Cancer Hospital, Xijing Hospital of Air Force Military Medical University | Neoadjuvant Treatment of Her2-positive Muscle-invasive Bladder Cance | 07/23 | 07/27 | | |
NCT06354231: DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC |
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| Recruiting | 2 | 20 | RoW | DV, RC48, Toripalimab, JS001, Laser surgery | Fudan University | Renal Insufficiency, Upper Urinary Tract Urothelial Carcinoma, Solitary Kidney | 12/26 | 12/26 | | |
