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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: Completed Phase 1 study, sponsored by Juno Therapeutics, a Subsidiary of Celgene.
NCT03430011 is a Phase 1 study that has completed, run by Juno Therapeutics, a Subsidiary of Celgene. The registered enrollment target is 165 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (175% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
DLT is defined as adverse events (AEs) that occur within 21 days following JCARH125 infusion and meet any of the following criteria: * Treatment-emergent Grade ≥3 allergic reactions related to JCARH125; * Treatment-emergent Grade 3 seizures, regardless of attribution, that do not resolve to Grade ≤2 within 3 days in participants who have no evidence of central nervous system (CNS) involvement of Multiple Myeloma or other CNS pathology; * Treatment-emergent autoimmune toxicity Grade ≥3, regardle
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 |
What the finished NCT03430011 record still lists
NCT03430011 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (175% higher).
The record links to 0 conditions, and to 2 interventions - of which JCARH125 is the first listed.
NCT03430011 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03430011's enrollment target sits among peer trials
165 332nd of 2000 higher than 1,666 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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