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NCT03430011 · ClinicalTrials.gov registry record · Phase 1
Study Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed and/or Refractory Multiple Myeloma
A Phase 1 study, sponsored by Juno Therapeutics, a Subsidiary of Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 165
- Enrollment target
NCT03430011 is a Phase 1 study that has completed, run by Juno Therapeutics, a Subsidiary of Celgene. The registered enrollment target is 165 participants.
The verdict
NCT03430011, a Phase 1 study, has completed, sponsored by Juno Therapeutics, a Subsidiary of Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 165 participants
- Enrollment target
Study Summary
This is an open-label, multicenter, Phase 1/2 study to determine the safety and efficacy of JCARH125, a CAR T-cell product that targets B-cell maturation antigen (BCMA), in adult subjects with relapsed and/or refractory multiple myeloma. The study will include a Phase 1 part to determine the recommended dose of JCARH125 in subjects with relapsed and/or refractory multiple myeloma, followed by a Phase 2 part to further evaluate the safety and efficacy of JCARH125 at the recommended dose. The safety and tolerability of JCARH125 in subjects who receive prophylactic treatment with anakinra will be evaluated in a separate Phase 1 cohort. The antitumor activity of JCARH125 in subjects who have been previously treated with BCMA-directed therapy will be evaluated in separate Phase 2a cohorts.
Interventions
- BIOLOGICAL JCARH125
- BIOLOGICAL JCARH125 + anakinra
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2018-02-01 |
| Est. Completion | 2023-03-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03430011
The ClinicalTrials.gov registry entry for NCT03430011 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 165 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Juno Therapeutics, a Subsidiary of Celgene, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which JCARH125 is the first listed.
NCT03430011 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03430011 about?
NCT03430011 is a clinical study titled "Study Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed and/or Refractory Multiple Myeloma". This is an open-label, multicenter, Phase 1/2 study to determine the safety and efficacy of JCARH125, a CAR T-cell product that targets B-cell maturation antigen (BCMA), in adult subjects with relapsed and/or refractory multiple myeloma. The study will include a Phase 1 part to determine the recomme...
What is the current status of trial NCT03430011?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 165 participants. The study started on 2018-02-01. Estimated completion is 2023-03-30.
What interventions are being tested in trial NCT03430011?
The interventions under investigation include: JCARH125 (BIOLOGICAL), JCARH125 + anakinra (BIOLOGICAL).
Who is sponsoring clinical trial NCT03430011?
This trial is sponsored by Juno Therapeutics, a Subsidiary of Celgene, which has 11 total clinical trials registered on ClinicalTrials.gov.
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