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1 Disease |  |
6 Trials |
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6 Trials |  |
74 News |  |
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- || mezagitamab (TAK-079) / Takeda
New P2 trial: A Study of TAK-079 in People With Generalized Myasthenia Gravis (clinicaltrials.gov) - Nov 15, 2019
P2, N=36, Not yet recruiting, Sponsor: Takeda
- Darzalex IV (daratumumab) / J&J
The Binding of CD38 Therapeutics to Red Blood Cells and Platelets Subverts Depletion of Target Cells (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_4331;
P1/2, P1b
An effective strategy for developing more potent therapeutics may be to circumvent binding to CD38 on circulating RBCs and PLTs because the magnitude of CD38 antibody binding to leukocytes is inversely related to binding of circulating RBCs and PLTs in vitro . In addition, lower binding to RBCs and PLTs is associated with higher availability of CD38 antibody for binding target cells in RRMM patients, as well as target saturation and depletion by TAK-079 when administered subcutaneously at relatively low doses (eg, 300mg).
- TAK-079 / Takeda
Preliminary Results from a Phase 1b Study of TAK-079, an Investigational Anti-CD38 Monoclonal Antibody (mAb) in Patients with Relapsed/ Refractory Multiple Myeloma (RRMM) (Hall E1, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_1450;
P1/2
TAK-079 SC has a low treatment burden with the low volume (2 mL) subcutaneous injections performed in ≤ 1-minute signifying the potential for home-based self-administration . The high potency of TAK-079 may result from selective binding to myeloma cells (ie less binding to RBC and platelets) .
- ||||| TAK-079 / Takeda
Clinical: A Phase 1/2a Study Investigating TAK-079 Administered Subcutaneously in Patients With Relapsed/Refractory Multiple Myeloma NCT03439280 | SparkCures https://t.co/pApohaqAxQ #myeloma (Twitter) - Nov 1, 2019
P1/2
- | Darzalex IV (daratumumab) / J&J
Review, Journal, IO Biomarker: CD38 Antibodies in Multiple Myeloma: Mechanisms of Action and Modes of Resistance. (Pubmed Central) - Oct 29, 2019
At this moment several CD38 antibodies are at different phases of clinical testing, with daratumumab already approved for various indications both as monotherapy and in combination with standards of care in MM...Furthermore, the microenvironment protects MM cells to CD38 antibody-induced ADCC by upregulation of anti-apoptotic molecules, such as survivin. Improved understanding of modes of action and mechanisms of resistance has resulted in rationally designed CD38-based combination therapies, which will contribute to further improvement in outcome of MM patients.
- | 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) - Sep 18, 2019
P1b, N=36, Recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Improved understanding of modes of action and mechanisms of resistance has resulted in rationally designed CD38-based combination therapies, which will contribute to further improvement in outcome of MM patients. Not yet recruiting --> Recruiting
- | mezagitamab (TAK-079) / Takeda
Enrollment change, Trial completion date, Trial primary 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) - Jul 15, 2019
P1/2, N=100, Recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Not yet recruiting --> Recruiting N=42 --> 100 | Trial completion date: Oct 2020 --> Dec 2022 | Trial primary completion date: Oct 2020 --> Feb 2022
- | Darzalex IV (daratumumab) / J&J
Review, Journal, PD(L)-1 Biomarker, IO Biomarker: Immunomodulatory effects of CD38-targeting antibodies. (Pubmed Central) - Jul 11, 2019
CD38-targeting antibodies probably also reduce adenosine production in the bone marrow microenvironment, which may contribute to improved T cell activity. Preclinical and clinical studies have demonstrated that CD38-targeting antibodies have synergistic activity with several other anti-cancer drugs, including various agents with immune stimulating activity, such as lenalidomide and pomalidomide, as well as PD1/PD-L1 inhibitors.
- || mezagitamab (TAK-079) / Takeda
New P1 trial, 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 12, 2019
P1b, N=36, Not yet recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
- || 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) - Dec 10, 2018
P1b, N=24, Recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Preclinical and clinical studies have demonstrated that CD38-targeting antibodies have synergistic activity with several other anti-cancer drugs, including various agents with immune stimulating activity, such as lenalidomide and pomalidomide, as well as PD1/PD-L1 inhibitors. Not yet recruiting --> Recruiting
- | mezagitamab (TAK-079) / Takeda
New P1 trial, 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) - Oct 30, 2018
P1b, N=24, Not yet recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
- | 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) - Sep 17, 2018
P1/2, N=42, Recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | mezagitamab (TAK-079) / Takeda
New P1/2 trial: 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) - Feb 20, 2018
P1/2, N=42, Not yet recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
- ||| mezagitamab (TAK-079) / Takeda
Trial completion: A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of TAK-079 in Healthy Participants (clinicaltrials.gov) - Jun 21, 2016
P1, N=82, Completed, Sponsor: Takeda
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- || mezagitamab (TAK-079) / Takeda
Enrollment closed: A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of TAK-079 in Healthy Participants (clinicaltrials.gov) - Mar 4, 2016
P1, N=82, Active, not recruiting, Sponsor: Takeda
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || mezagitamab (TAK-079) / Takeda
Trial initiation date, Trial primary completion date: A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of TAK-079 in Healthy Participants (clinicaltrials.gov) - Sep 14, 2015
P1, N=82, Recruiting, Sponsor: Takeda
Recruiting --> Active, not recruiting Initiation date: Aug 2014 --> Aug 2015 | Trial primary completion date: Jul 2015 --> Feb 2016
- ||| mezagitamab (TAK-079) / Takeda
New P1 trial: A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of TAK-079 in Healthy Participants (clinicaltrials.gov) - Aug 19, 2014
P1, N=82, Recruiting, Sponsor: Takeda