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NCT04093596 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)
A Phase 1 study of Relapsed/Refractory Multiple Myeloma, sponsored by Allogene Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 132
- Enrollment target
- 11
- Study locations
NCT04093596: Active Phase 1 study of Relapsed/Refractory Multiple Myeloma, sponsored by Allogene Therapeutics.
NCT04093596 is a Phase 1 study of Relapsed/Refractory Multiple Myeloma that is active but no longer recruiting, run by Allogene Therapeutics. The registered enrollment target is 132 participants, below the 163-participant average among 14 other Relapsed/Refractory Multiple Myeloma trials with a reported enrollment target (19% lower). The trial reports 11 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04093596, a Phase 1 study of Relapsed/Refractory Multiple Myeloma, is active but no longer recruiting, sponsored by Allogene Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 132 participants
- Enrollment target
- 11
- Study locations
Study Summary
The purpose of the UNIVERSAL study is to assess the safety, efficacy, cell kinetics, and immunogenicity of ALLO-715 with or without Nirogacestat in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen of ALLO-647 in combination with fludarabine and/or cyclophosphamide, or ALLO-647 alone.
Primary Outcome
Dose limiting toxicities are defined as ALLO-715-related adverse events with onset within 28 days following infusion of ALLO-715.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Nirogacestat
- BIOLOGICAL ALLO-647
- GENETIC ALLO-715
Study Locations (11)
California
- City of Hope - Duarte
- Stanford Cancer Institute - Palo Alto
Texas
- St. David's South Austin Medical Center - Austin
- Texas Transplant Institute - San Antonio
Arizona
- Banner MD Anderson Cancer Center - Gilbert
Colorado
- Sarah Cannon/Colorado Blood Cancer Institute - Denver
Minnesota
- Mayo Clinic - Rochester
New York
- Memorial Sloan Kettering Cancer Center - New York
Ohio
- Cleveland Clinic Taussig Cancer Center - Cleveland
Tennessee
- Vanderbilt-Ingram Cancer Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2019-09-23 |
| Est. Completion | 2027-09 |
| Phase | Phase 1 |
What the registry record for NCT04093596 still lists
NCT04093596 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 163-participant average among 14 other Relapsed/Refractory Multiple Myeloma trials with a reported enrollment target (19% lower).
The record links to 1 condition, with Relapsed/Refractory Multiple Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT04093596 lists 11 locations in 9 states (California, Texas, Arizona).
Frequently Asked Questions
What is clinical trial NCT04093596 about?
NCT04093596 is a clinical study titled "Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)". The purpose of the UNIVERSAL study is to assess the safety, efficacy, cell kinetics, and immunogenicity of ALLO-715 with or without Nirogacestat in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen of ALLO-647 in combination with fludarabine and/or cyclophosphamide,...
What is the current status of trial NCT04093596?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 132 participants. The study started on 2019-09-23. Estimated completion is 2027-09.
What conditions does trial NCT04093596 study?
This clinical trial studies the following conditions: Relapsed/Refractory Multiple Myeloma.
What interventions are being tested in trial NCT04093596?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Nirogacestat (DRUG), ALLO-647 (BIOLOGICAL), ALLO-715 (GENETIC).
Who is sponsoring clinical trial NCT04093596?
This trial is sponsored by Allogene Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04093596 being conducted?
This trial has 11 study locations across Arizona, California, Colorado, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Relapsed/Refractory Multiple Myeloma
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Where NCT04093596's enrollment target sits among peer trials
132 7th of 14 higher than 8 of 14 other Relapsed/Refractory Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Relapsed/Refractory Multiple Myeloma 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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