 |
1 Disease |  |
6 Trials |
|
6 Trials |  |
74 News |  |
| 12» |
- mezagitamab (TAK-079) / Takeda
Safety, tolerability, and efficacy of mezagitamab (TAK-079) in chronic or persistent primary immune thrombocytopenia: Interim results from a phase 2, randomized, double-blind, placebo-controlled study (Plenary Hall) - Jun 17, 2024 - Abstract #ISTH2024ISTH_2471;
- | mezagitamab (TAK-079) / Takeda
Phase classification, Trial completion date, Trial primary completion date, Combination therapy: A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (clinicaltrials.gov) - Apr 30, 2024
P1, N=50, Active, not recruiting, Sponsor: Takeda
Phase classification: P1b --> P1 | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025
- ||| subasumstat (TAK-981) / Takeda
Phase classification, Trial termination, Combination therapy: A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM) (clinicaltrials.gov) - Jan 4, 2024
P1/2, N=27, Terminated, Sponsor: Takeda
Phase classification: P1b --> P1 | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025 Phase classification: P1b/2 --> P1/2 | Active, not recruiting --> Terminated; Enrolment Challenges
- || Review, Journal: Efficacy and safety of the innovative monoclonal antibodies in adults with generalized myasthenia gravis: a Bayesian network analysis. (Pubmed Central) - Dec 3, 2023
For QMG score, batoclimab 340mg (MD ranged from 4.32 to 8.52) and batoclimab 680mg (MD ranged from 4.11 to 9.31) were more effective than placebo and other monoclonal antibodies except for rozanolixzumab, with the highest SUCRA value (93% and 97% respectively)...Given the limitations inherent in indirect comparisons, further head-to-head and extensive observational studies are necessary to confirm our findings. https://inplasy.com/?s=202370112, identifier 202370112.
- ||| subasumstat (TAK-981) / Takeda
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy: A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM) (clinicaltrials.gov) - Oct 13, 2023
P1b/2, N=27, Active, not recruiting, Sponsor: Takeda
https://inplasy.com/?s=202370112, identifier 202370112. Recruiting --> Active, not recruiting | N=81 --> 27 | Trial completion date: Aug 2026 --> Nov 2023 | Trial primary completion date: Feb 2025 --> Aug 2023
- || Review, Journal: Novel therapeutics and future directions for refractory immune thrombocytopenia. (Pubmed Central) - Sep 26, 2023
This manuscript offers an in-depth review of the current available data for novel therapeutics in ITP presently undergoing phase 2 or 3 studies in patients with heavily pretreated or refractory ITP. It additionally highlights the future directions for drug development in refractory ITP, including discussion of innovative clinical trial designs, health-related quality of life as an indispensable clinical trial end-point and balancing potential toxicities of drugs with their potential benefits in a bleeding disorder in which few patients suffer life-threatening bleeding.
- | mezagitamab (TAK-079) / Takeda
Trial completion date, Trial primary completion date, Combination therapy: A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (clinicaltrials.gov) - Jul 17, 2023
P1b, N=50, Active, not recruiting, Sponsor: Takeda
It additionally highlights the future directions for drug development in refractory ITP, including discussion of innovative clinical trial designs, health-related quality of life as an indispensable clinical trial end-point and balancing potential toxicities of drugs with their potential benefits in a bleeding disorder in which few patients suffer life-threatening bleeding. Trial completion date: Mar 2023 --> Feb 2024 | Trial primary completion date: Mar 2023 --> Feb 2024
- | mezagitamab (TAK-079) / Takeda
Trial primary completion date: A Study of TAK-079 in People With Generalized Myasthenia Gravis (clinicaltrials.gov) - Mar 17, 2023
P2, N=36, Completed, Sponsor: Takeda
Trial completion date: Mar 2023 --> Feb 2024 | Trial primary completion date: Mar 2023 --> Feb 2024 Trial primary completion date: Mar 2022 --> Jul 2022
- || subasumstat (TAK-981) / Takeda
Trial completion date, Trial primary completion date, Combination therapy: A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM) (clinicaltrials.gov) - Jan 25, 2023
P1b/2, N=81, Recruiting, Sponsor: Takeda
Trial primary completion date: Mar 2022 --> Jul 2022 Trial completion date: Oct 2025 --> Aug 2026 | Trial primary completion date: Oct 2024 --> Feb 2025
- || Review, Journal, IO biomarker: Targeting CD38 in Neoplasms and Non-Cancer Diseases. (Pubmed Central) - Sep 13, 2022
Also, novel therapeutics such as SAR442085 aim to outrank the older antibodies against CD38...This review focuses on targeting CD38 in cancer and non-cancerous diseases using antibodies, cell-based therapies and CD38 inhibitors. We also provide a summary of current clinical trials targeting CD38.
- || mezagitamab (TAK-079) / Takeda
Trial completion date, Trial primary completion date: A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia (clinicaltrials.gov) - Sep 8, 2022
P2, N=54, Recruiting, Sponsor: Takeda
We also provide a summary of current clinical trials targeting CD38. Trial completion date: May 2023 --> Aug 2024 | Trial primary completion date: Sep 2022 --> Aug 2024
- || mezagitamab (TAK-079) / Takeda
.@TakedaPharma has an anti-CD38 mAb TAK-079 that they are using for refractory ITP. We opened it @The_BMC and it’s also @MGHMedicine. It’s been hard to get people on that meet criteria. https://t.co/DnYTo3Sf14 (Twitter) - Aug 3, 2022
- || mezagitamab (TAK-079) / Takeda
Trial completion: A Study of TAK-079 in People With Generalized Myasthenia Gravis (clinicaltrials.gov) - Aug 1, 2022
P2, N=36, Completed, Sponsor: Takeda
Trial completion date: May 2023 --> Aug 2024 | Trial primary completion date: Sep 2022 --> Aug 2024 Active, not recruiting --> Completed
- || mezagitamab (TAK-079) / Takeda
Enrollment open, Combination therapy: A Study of Mezagitamab in Adults With Primary Immunoglobulin A Nephropathy Receiving Stable Background Therapy (clinicaltrials.gov) - May 23, 2022
P1b, N=16, Recruiting, Sponsor: Takeda
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- ||| mezagitamab (TAK-079) / Takeda
Trial completion, Enrollment change, Trial completion date: A Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Participants With Relapsed/Refractory (r/r) Multiple Myeloma (MM) (clinicaltrials.gov) - May 5, 2022
P1/2, N=50, Completed, Sponsor: Millennium Pharmaceuticals, Inc.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed | N=100 --> 50 | Trial completion date: Dec 2022 --> Jan 2022
- | mezagitamab (TAK-079) / Takeda
Enrollment closed: A Study of TAK-079 in People With Generalized Myasthenia Gravis (clinicaltrials.gov) - Apr 28, 2022
P2, N=36, Active, not recruiting, Sponsor: Takeda
Active, not recruiting --> Completed | N=100 --> 50 | Trial completion date: Dec 2022 --> Jan 2022 Recruiting --> Active, not recruiting
- |||| CD38 Abs in myeloma Daratumumab : Fully human Isatuximab: Chimeric MOR202: Fully human TAK-079: Fully human #mmsm #MYELOMA #USMRC #MedEd #MedTwitter (Twitter) - Feb 11, 2022
- || mezagitamab (TAK-079) / Takeda
New P1 trial, Combination therapy: A Study of Mezagitamab in Adults With Primary Immunoglobulin A Nephropathy Receiving Stable Background Therapy (clinicaltrials.gov) - Dec 29, 2021
P1b, N=16, Not yet recruiting, Sponsor: Takeda
- ||| mezagitamab (TAK-079) / Takeda
Trial completion, Enrollment change, Combination therapy, IO biomarker: A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - Nov 10, 2021
P1b, N=58, Completed, Sponsor: Millennium Pharmaceuticals, Inc.
Recruiting --> Active, not recruiting Active, not recruiting --> Completed | N=24 --> 58
- Darzalex IV (daratumumab) / J&J, subasumstat (TAK-981) / Takeda
Phase 1b/2 Study of the First-in-Class SUMO-Activating Enzyme Inhibitor TAK-981 in Combination with Monoclonal Antibodies in Patients with Triple-Class Refractory Multiple Myeloma (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_4384;
P1b/2
The iBOIN design selects the true maximum tolerated dose (if any) with high accuracy by allocating more patients to dose levels with a prior dose-limiting toxicity probability closest to the target of 0.3. This study is currently enrolling patients, with the first patient dosed in May 2021.
- || mezagitamab (TAK-079) / Takeda
Enrollment change, Trial primary completion date, Combination therapy: A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (clinicaltrials.gov) - Aug 18, 2021
P1b, N=50, Active, not recruiting, Sponsor: Takeda
This study is currently enrolling patients, with the first patient dosed in May 2021. N=36 --> 50 | Trial primary completion date: Aug 2021 --> Mar 2023
- || mezagitamab (TAK-079) / Takeda
Clinical, PK/PD data, Journal: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Anti-CD38 Cytolytic Antibody TAK-079 in Healthy Subjects. (Pubmed Central) - Jul 30, 2021
TAK-079 was well tolerated and s.c. administration elicited more durable reductions in plasmablasts and NK cells. This plasmacytolytic profile could be useful for treating disorders caused by plasma or NK cells, malignant counterparts, and/or pathogenic antibodies.
- ||| subasumstat (TAK-981) / Takeda
Enrollment open, Combination therapy: A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM) (clinicaltrials.gov) - Apr 9, 2021
P1b/2, N=81, Recruiting, Sponsor: Takeda
This plasmacytolytic profile could be useful for treating disorders caused by plasma or NK cells, malignant counterparts, and/or pathogenic antibodies. Not yet recruiting --> Recruiting
- | Darzalex IV (daratumumab) / J&J
Journal, IO biomarker: CD38: Targeted therapy in multiple myeloma and therapeutic potential for solid cancers. (Pubmed Central) - Mar 5, 2021
Other CD38 monospecific antibodies, such as isatuximab, MOR202, and TAK079, showed promising effects in clinical trials...There is convincing evidence that CD38-targeted immunotherapeutics reduce CD38 immune suppressor cells. This result suggests that CD38 can be exploited to treat solid tumors by regulating the immunosuppressive microenvironment.
- | mezagitamab (TAK-079) / Takeda
Trial completion date, Trial primary completion date: A Study of TAK-079 in People With Generalized Myasthenia Gravis (clinicaltrials.gov) - Mar 3, 2021
P2, N=36, Recruiting, Sponsor: Takeda
This result suggests that CD38 can be exploited to treat solid tumors by regulating the immunosuppressive microenvironment. Trial completion date: May 2021 --> Jun 2022 | Trial primary completion date: Feb 2021 --> Apr 2022
- mezagitamab (TAK-079) / Takeda
[VIRTUAL] Mezagitamab Induces Immunomodulatory Effect in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) (Channel 3 (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_3042;
P1/2
Conclusions Chronic treatment with mezagitamab is immunomodulatory in patients with RRMM, which is associated with reductions in tumor burden, subpopulations of B and T regulatory cells, and characterized by conventional NK and T cells exhibiting an activated, proliferative and effector phenotype. The immune landscape changes observed is consistent with the immunologic concept of converting the tumor microenvironment from cold-to-hot and highlights a key mechanistic effect of mezagitamab.
- | mezagitamab (TAK-079) / Takeda
Trial completion date, Trial primary completion date, Combination therapy: A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (clinicaltrials.gov) - Oct 28, 2020
P1b, N=36, Recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
The immune landscape changes observed is consistent with the immunologic concept of converting the tumor microenvironment from cold-to-hot and highlights a key mechanistic effect of mezagitamab. Trial completion date: Feb 2022 --> May 2023 | Trial primary completion date: Oct 2020 --> Aug 2021
- ||| mezagitamab (TAK-079) / Takeda
Enrollment open: A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia (clinicaltrials.gov) - Aug 30, 2020
P2, N=54, Recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Trial completion date: Feb 2022 --> May 2023 | Trial primary completion date: Oct 2020 --> Aug 2021 Not yet recruiting --> Recruiting
- || mezagitamab (TAK-079) / Takeda
Enrollment open, Combination therapy, IO biomarker: A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - Aug 28, 2020
P1b, N=24, Recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Not yet recruiting --> Recruiting Active, not recruiting --> Recruiting
- ||||| TAK-079 / Takeda
Clinical, Monotherapy, Video: Monotherapy with TAK-079, an investigational anti-CD38 monoclonal antibody, was safe and well-tolerated in patients with relapsed/refractory multiple #myeloma. In this video, study author @DoctorAKrishnan, MD, discusses the findings. https://t.co/CdkoYSU3yW (Twitter) - Jul 28, 2020
- | mezagitamab (TAK-079) / Takeda
Trial completion date, Trial primary completion date, Combination therapy, IO biomarker: A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - Jun 9, 2020
P1b, N=24, Active, not recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Active, not recruiting --> Recruiting Trial completion date: Dec 2020 --> Feb 2022 | Trial primary completion date: May 2020 --> Nov 2021
- ||| mezagitamab (TAK-079) / Takeda
Enrollment open: A Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Participants With Relapsed/Refractory (r/r) Multiple Myeloma (MM) (clinicaltrials.gov) - Jun 9, 2020
P1/2, N=100, Recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Trial completion date: Dec 2020 --> Feb 2022 | Trial primary completion date: May 2020 --> Nov 2021 Active, not recruiting --> Recruiting
- || mezagitamab (TAK-079) / Takeda
Enrollment open, Combination therapy: A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (clinicaltrials.gov) - Jun 9, 2020
P1b, N=36, Recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Active, not recruiting --> Recruiting Active, not recruiting --> Recruiting
- || mezagitamab (TAK-079) / Takeda
Trial initiation date: A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia (clinicaltrials.gov) - May 28, 2020
P2, N=54, Not yet recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Active, not recruiting --> Recruiting Initiation date: May 2020 --> Sep 2020
- TAK-079 / Takeda, danazol oral / Generic mfg.
[VIRTUAL] A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE SAFETY, TOLERABILITY AND EFFICACY OF TAK-079 IN PATIENTS WITH ITP () - May 16, 2020 - Abstract #EHA2020EHA_2545;
P2
There are no results data available. Conclusion This study is designed to evaluate the safety, tolerability, efficacy and durability of platelet response of TAK-079 vs. placebo in patients with ITP (NCT04278924).
- TAK-079 / Takeda
[VIRTUAL] A PHASE 1B STUDY OF TAK-079, AN INVESTIGATIONAL ANTI-CD38 MONOCLONAL ANTIBODY (MAB) IN PATIENTS WITH RELAPSED/ REFRACTORY MULTIPLE MYELOMA (RRMM): PRELIMINARY RESULTS () - May 16, 2020 - Abstract #EHA2020EHA_1604;
P1/2
PFS, with a median FU of 7.5 months at the data-cut off, is not estimable at the RP2 dose. Updated safety and efficacy data will be presented.
- || mezagitamab (TAK-079) / Takeda
Enrollment closed: A Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Participants With Relapsed/Refractory (r/r) Multiple Myeloma (MM) (clinicaltrials.gov) - May 3, 2020
P1/2, N=100, Active, not recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Updated safety and efficacy data will be presented. Recruiting --> Active, not recruiting
- || mezagitamab (TAK-079) / Takeda
Enrollment closed, Combination therapy, IO biomarker: A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - May 1, 2020
P1b, N=24, Active, not recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- || mezagitamab (TAK-079) / Takeda
Enrollment closed, Combination therapy: A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (clinicaltrials.gov) - Apr 30, 2020
P1b, N=36, Active, not recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- TAK-079 / Takeda
[VIRTUAL] The pharmacokinetics and pharmacodynamics of the CD38 antibody TAK-079 after subcutaneous administration to relapsed/refractory myeloma patients. () - Apr 29, 2020 - Abstract #ASCO2020ASCO_5295;
- TAK-079 / Takeda
[VIRTUAL] A phase Ib study of TAK-079, an investigational anti-CD38 monoclonal antibody (mAb) in patients with relapsed/ refractory multiple myeloma (RRMM): Preliminary results. (Poster Board 439) - Apr 29, 2020 - Abstract #ASCO2020ASCO_2245;
P1/2
Clinical activity occurred early and was durable. With no MTD identified, no IRRs, no significant hematologic toxicity, the RP2 dose is 600 mg.
- || Decadron (dexamethasone) / Merck (MSD), Darzalex IV (daratumumab) / J&J
Review, Journal: Resistance Mechanisms Towards CD38-Directed Antibody Therapy in Multiple Myeloma. (Pubmed Central) - Apr 28, 2020
Further, the other CD38-targeting antibodies (i.e., MOR202 and TAK-079) are increasingly used in clinical trials...Therefore, it is important to gain insight into the mechanisms of resistance to CD38-targeting antibodies in MM, and to develop strategies to overcome this resistance. In the current review, we will briefly describe the most important clinical data and mechanisms of action and will focus in depth on the current knowledge on mechanisms of resistance to CD38-targeting antibodies and potential strategies to overcome this.
- |||| mezagitamab (TAK-079) / Takeda
New P2 trial: A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia (clinicaltrials.gov) - Feb 19, 2020
P2, N=54, Not yet recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
- || mezagitamab (TAK-079) / Takeda
Enrollment open: A Study of TAK-079 in People With Generalized Myasthenia Gravis (clinicaltrials.gov) - Jan 6, 2020
P2, N=36, Recruiting, Sponsor: Takeda
In the current review, we will briefly describe the most important clinical data and mechanisms of action and will focus in depth on the current knowledge on mechanisms of resistance to CD38-targeting antibodies and potential strategies to overcome this. Not yet recruiting --> Recruiting
- | Decadron (dexamethasone) / Merck (MSD), Darzalex IV (daratumumab) / J&J, TAK-079 / Takeda
Journal, IO Biomarker: A reduction in B, T, and NK cells expressing CD38 by TAK-079 inhibits the induction and progression of collagen-induced arthritis in cynomolgus monkeys. (Pubmed Central) - Jan 1, 2020
SIGNIFICANCE STATEMENT: This study demonstrates that targeting CD38-expressing leukocytes with a cytolytic antibody can ameliorate autoimmune disease in cynomolgus monkeys. The study gives a unique perspective into this therapeutic strategy because the three other anti-CD38 cytolytic antibodies in clinical development (daratumumab, isatuximab, and MOR202) cannot be tested in similar models because they do not cross-react with CD38 expressed by new world primates.
- ||| TAK-079 / Takeda
Unlike Dara, which is a kappa MOAB, TAK-079 is a lambda antiCD+38 MOAB. #ASH19 #IMFASH19 @IMFmyeloma No infusion-related reactions reported. (Twitter) - Dec 7, 2019
- ||||| isatuximab (SAR650984) / Sanofi, TAK-079 / Takeda
Clinical: Data on anti CD38 antibody TAK 079 looking good. Curious to know what would be the effect of adding dexamethasone (similar to how it enhances efficacy of isatuximab). #ASH19 (Twitter) - Dec 7, 2019
- ||||| TAK-079 / Takeda
Dr Krishnan presents on Ph 1 TAK-079 anti CD38. More than 3 lines and prior IMID/PI n=34. No MTD yet at 1200. Neutropenia possible. No IRR. Mostly PR. At 600 mg 75% PFS at 6 months. ORR 56-33% (300-600 mg) #ASH19RF #mmsm https://t.co/LvR5sv6qVC #ASH19 (Twitter) - Dec 7, 2019
- |||||| TAK-079 / Takeda
Clinical: TAK it on time the CD38 list! TAK-079 anti CD38 Moab. SubQ and safe. ORR 36/56% in Dara naive RRMM pts. Median PFS not reached yet #mmsm #ASH19 (Twitter) - Dec 7, 2019