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NCT03502577 · ClinicalTrials.gov registry record · Phase 1
BCMA-Specific CAR T-Cells Combined With a Gamma Secretase Inhibitor (JSMD194) to Treat Relapsed or Persistent Multiple Myeloma
A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT03502577: Clinical Trial Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
NCT03502577 is a Phase 1 study that was terminated before completion, run by Fred Hutchinson Cancer Center. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03502577, a Phase 1 study, was terminated before completion, sponsored by Fred Hutchinson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
This phase I trial determines the side effects and best dose of B-cell maturation antigen (BCMA)-chimeric antigen receptor (CAR) T-cells when combined with gamma-secretase inhibitor LY3039478 (JSMD194), cyclophosphamide, and fludarabine in treating participants with multiple myeloma that that has come back or remains despite treatment. Placing genes added in the laboratory into immune T-cells may make the T-cells recognize BCMA, a protein on the surface of cancer cells. JSMD194 may enhance the killing of cancer cells by increasing the BCMA expression on multiple myeloma cells, making the targeted BCMA CAR-T treatment more effective. JSMD194 also decreases the amount of BCMA found in the circulation (called soluble BCMA) that is not bound to the myeloma cells. JSMD194 can therefore reduce the potential for soluble BCMA to act as a decoy. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving BCMA CAR T therapy with JSMD194, cyclophosphamide, and fludarabine may work better in treating participants with relapsed or persistent multiple myeloma.
Primary Outcome
This is defined as the dose associated with a true dose-limiting toxicity (DLT) rate of 25% in each of the cohorts. DLTs are events that occur within the first 28 days following CAR T-cell infusion.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL BCMA-specific CAR-expressing T Lymphocytes
- DRUG Gamma-Secretase Inhibitor LY3039478
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2018-05-23 |
| Est. Completion | 2022-04-20 |
| Phase | Phase 1 |
Why NCT03502577 stopped before completion
NCT03502577 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03502577 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03502577 about?
NCT03502577 is a clinical study titled "BCMA-Specific CAR T-Cells Combined With a Gamma Secretase Inhibitor (JSMD194) to Treat Relapsed or Persistent Multiple Myeloma". This phase I trial determines the side effects and best dose of B-cell maturation antigen (BCMA)-chimeric antigen receptor (CAR) T-cells when combined with gamma-secretase inhibitor LY3039478 (JSMD194), cyclophosphamide, and fludarabine in treating participants with multiple myeloma that that has co...
What is the current status of trial NCT03502577?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2018-05-23. Estimated completion is 2022-04-20.
What interventions are being tested in trial NCT03502577?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Laboratory Biomarker Analysis (OTHER), BCMA-specific CAR-expressing T Lymphocytes (BIOLOGICAL), Gamma-Secretase Inhibitor LY3039478 (DRUG).
Who is sponsoring clinical trial NCT03502577?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03502577's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 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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