| Hyleukin-7 (efineptakin alfa) / Genexine, NeoImmuneTech |
NCT04810637: A Study to Evaluate the Safety and Efficacy of GX-I7 in Elderly Patients With Asymptomatic or Mild Symptoms of COVID-19 |
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| Recruiting | 2 | 210 | RoW | GX-I7, Efineptakin alfa NT-I7, rhIL-7-hyFc, NT-I7, TJ107 | PT Kalbe Genexine Biologics, Genexine, Inc. | Covid19 | 06/21 | 09/21 | | |
NCT05145907: Study to Evaluate Safety and Efficacy of TJ107 Combine With PD-1 in Patients With Solid Tumors |
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| Active, not recruiting | 2 | 133 | RoW | TJ107 +Pembrolizumab | TJ Biopharma Co., Ltd. | Triple-negative Breast Cancer, Head and Neck Squamous Cell Carcinoma | 06/24 | 12/24 | | |
NCT04600817: A Study to Evaluate the Efficacy and Safety of TJ107 in Lympopenic Patients With Newly Diagnosed Glioblastoma Who Completed Standard Concurrent Chemoradiotherapy (CCRT) |
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| Active, not recruiting | 2 | 160 | RoW | TJ107, TJ107 placebo | TJ Biopharma Co., Ltd. | Newly Diagnosed Glioblastoma | 12/24 | 12/24 | | |
NCT04984811: NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC |
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| Active, not recruiting | 2 | 83 | US | efineptakin alfa, NT-I7, Atezolizumab, Tecentriq | NeoImmuneTech, Roche Pharma AG | Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma, Nonsmall Cell Lung Cancer, Non Small Cell Lung Cancer | 09/24 | 03/25 | | |
NCT05465954: Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma |
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| Recruiting | 2 | 34 | US | Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Efineptakin alfa, GX-I7, Hyleukin-7 (TM), Il-7 Hybrid Fc, IL-7-hyFc, NT-I7, rhIL-7-hyFc, TJ 107, TJ-107, TJ107, Pembrolizumab, Keytruda, Lambrolizumab, MK-3475, SCH 900475 | Mayo Clinic, NeoImmune Tech, Merck Sharp & Dohme LLC | High Grade Astrocytic Tumor, Recurrent Glioblastoma, IDH-Wildtype, Recurrent Gliosarcoma | 10/24 | 10/25 | | |
NCT05191784: GX-I7 in Combination With Bevacizumab in Recurrent Glioblastoma (GBM) Patients |
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| Active, not recruiting | 2 | 20 | RoW | GX-I7, rhIL-7-hyFc, Efineptakin alfa, Bevacizumab, Avastin | Genexine, Inc. | Recurrent Glioblastoma | 12/24 | 12/24 | | |
GENUINE, NCT05286060: Trial of the Combination of GX-188E Vaccination, GX-I7 and Pembrolizumab in Patients With Advanced, Resectable HPV Type 16 and/or 18 Positive Head and Neck Cancer |
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| Recruiting | 2 | 56 | RoW | GX-188E, GX-I7, Pembrolizumab, GX-188E, Pembrolizumab, GX-188E, GX-I7 | Yonsei University, Genexine, Inc., NeoImmuneTech | Head and Neck Squamous Cell Carcinoma | 08/25 | 12/25 | | |
TRINITY, NCT05280457: HPV 16-positive and/or HPV 18-positive Recurrent and/or For Patients With Metastatic Head and Neck Cancer to Evaluate GX-188E DNA Vaccination, GX-I7 and Nivolumab Combination Therapy |
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| Recruiting | 2 | 21 | RoW | nivolumab-GX-188E-GX-I7 | Yonsei University | Head and Neck Squamous Cell Carcinoma | 03/26 | 03/26 | | |
KEYNOTE-899, NCT03752723: Study of GX-I7 in Combination With Pembrolizumab in Refractory or Relapsed (R/R) TNBC Subjects(GX-I7-CA-006/) |
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| Completed | 1/2 | 84 | RoW | GX-I7, Efineptakin alfa, Pembrolizumab(KEYTRUDA®), KEYTRUDA®, MK-3745, Cyclophosphamide | Genexine, Inc., Merck Sharp & Dohme LLC | Triple Negative Breast Cancer | 05/23 | 05/23 | | |
NCT03901573: High-Risk Skin Cancers With Atezolizumab Plus NT-I7 |
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| Terminated | 1/2 | 31 | US | NT-I7, efineptakin alfa, rhIL-7-hyFc, atezolizumab, Tecentriq | NeoImmuneTech, Immune Oncology Network | Melanoma, Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma | 08/23 | 08/23 | | |
KEYNOTE A60, NCT04332653: NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors |
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| Active, not recruiting | 1/2 | 215 | US | NT-I7, Efineptakin alfa, rhIL-7-hyFc, pembrolizumab (KEYTRUDA®), KEYTRUDA® | NeoImmuneTech, Merck Sharp & Dohme LLC | Any Advanced Solid Tumors, Triple Negative Breast Cancer, Non Small Cell Lung Cancer, Small Cell Lung Cancer, Microsatellite Stable Colorectal Cancer, Pancreatic Cancer, Ovarian Cancer | 11/24 | 03/25 | | |
NCT05600920: A Single-arm, Dose-escalation Trial of Long-acting Recombinant Human IL-7 (NT-I7, Efineptakin Alfa) for Idiopathic CD4 Lymphopenia |
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| Not yet recruiting | 1/2 | 60 | US | Recombinant human interleukin (IL) 7-hyFc | National Institute of Allergy and Infectious Diseases (NIAID), NeoImmune Tech | Idiopathic CD4 Lymphopenia | 11/26 | 11/26 | | |
NCT03687957: rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temzolomide |
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| Recruiting | 1/2 | 70 | US | rhIL-7-hyFc, Placebo, Temozolomide, TMZ, Radiation therapy, RT, Blood sample | Washington University School of Medicine, NeoImmuneTech, The Foundation for Barnes-Jewish Hospital | Glioma | 01/32 | 01/32 | | |
NCT04380948: A Pilot Study Evaluating the Effect of NT-I7, a Long Acting Interleukin-7, to Enhance Immune Clearance of SARS-CoV-2 (COVID-19) |
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| Not yet recruiting | 1 | 30 | US | NT-17, Placebo, Supportive care, Peripheral blood draw | Washington University School of Medicine | COVID-19, SARS-CoV-2 | 02/21 | 02/21 | | |
| Terminated | 1 | 7 | US | Double-Blind NT-I7, rhIL-7-hyFc, efineptakin alfa, Double-Blind Placebo | NeoImmuneTech, National Institute of Allergy and Infectious Diseases (NIAID), University of Nebraska | COVID-19 | 07/21 | 02/23 | | |
NCT04476290: A Double-Blind, Randomized, Placebo-Controlled, Phase 1, Single-Dose, Dose-Escalating Trial of Long-Acting Recombinant Human IL-7 (NT-I7) for COVID-19 |
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| Recruiting | 1 | 60 | US | Recombinant human interleukin 7-hyFc, Placebo | National Institute of Allergy and Infectious Diseases (NIAID) | SARs CoV 2 | 12/21 | 12/21 | | |
NCT02659800: Study of the Effect NT-I7 on CD4 Counts in Patients With High Grade Gliomas |
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| Terminated | 1 | 12 | US | Laboratory Biomarker Analysis, NT-I7, Placebo | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, National Cancer Institute (NCI), NeoImmuneTech | Lymphopenia, Malignant Glioma | 03/22 | 10/23 | | |
NCT06344715: Phase 1 Study Evaluating Safety and Tolerability of SL-T10, GX-I7, and Pembrolizumab Triple Combination in mCRPC. |
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| Recruiting | 1 | 78 | RoW | SL-T10, GX-I7, Pembrolizumab | SL VAXiGEN | Metastatic Castration-resistant Prostate Cancer (mCRPC) | 10/24 | 10/24 | | |
| Terminated | 1 | 10 | Europe, US | NT-I7, Efineptakin alfa, rhIL-7-hyFc, Nivolumab | NeoImmuneTech, Bristol-Myers Squibb | Gastric or Gastro-esophageal Junction (GEJ) or Esophageal Adenocarcinoma (EAC) | 05/23 | 05/23 | | |
| Withdrawn | 1 | 68 | US | Recombinant human IL-7-hyFc (NT-I7), Vaccine sequence 1, Vaccine sequence 2 | National Cancer Institute (NCI), NeoImmuneTech | Breast Carcinoma, Colorectal Adenocarcinoma, Bladder Carcinoma | 11/23 | 11/23 | | |
NCT04893018: NT-I7 for Kaposi Sarcoma in Patients With or Without HIV |
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| Terminated | 1 | 8 | US | Efineptakin alfa, 2026634-47-7, GX-I7, Hyleukin-7 (TM), Il-7 Hybrid Fc, IL-7-hyFc, NT-I7, rhIL-7-hyFc | Fred Hutchinson Cancer Center, Cancer Immunotherapy Trials Network (CITN), National Cancer Institute (NCI) | AIDS-Related Kaposi Sarcoma, HIV Infection, Kaposi Sarcoma | 12/23 | 12/23 | | |
NCT04588038: NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery |
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| Recruiting | 1 | 10 | US | Efineptakin alfa, GX-I7, Hyleukin-7 (TM), Il-7 Hybrid Fc, IL-7-hyFc, NT-I7, rhIL-7-hyFc, TJ 107, TJ-107, TJ107 | Hyunseok Kang, MD, NeoImmuneTech | Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Oral Cavity Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Resectable Oropharyngeal Squamous Cell Carcinoma | 03/25 | 03/25 | | |
NCT05075603: Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy |
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| Recruiting | 1 | 57 | US | Efineptakin alfa, NT-I7, rhIL-7-hyFc, Tisagenlecleucel, Kymriah, Axicabtagene ciloleucel, Yescarta, Lisocabtagene Maraleucel, Breyanzi | NeoImmuneTech | Refractory Diffuse Large B-cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Recurrent Diffuse Large B-Cell Lymphoma, Refractory High Grade B-Cell Lymphoma, Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma | 11/24 | 02/26 | | |
NCT04781309: NT-I7, a Long-Acting Recombinant IL-7 Molecule, as an Immune Reconstitution Strategy for Lymphopenia in Patients With Progressive Multifocal Leukoencephalopathy |
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| Recruiting | 1 | 12 | US | NT-I7 | National Institute of Neurological Disorders and Stroke (NINDS), NeoImmuneTech | Progressive Multifocal Leukoencephalopathy | 01/26 | 01/26 | | |
| No Longer Available | N/A | | RoW | GX-I7 | Genexine, Inc. | Glioblastoma, High Grade Glioma, Recurrent Glioblastoma, Melanoma, Advanced Cancer | | | | |