Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)
NCT04093596 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 73
Last updated 2026-05-13
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.
Conditions
Interventions
- DRUG
-
Nirogacestat
a small molecule, selective, reversible, noncompetitive inhibitor of γsecretase (GSI) that increases BCMA target density on the surface of multiple myeloma cells.
- GENETIC
-
ALLO-715
ALLO-715 is an allogeneic CAR T cell therapy targeting BCMA
- BIOLOGICAL
-
ALLO-647
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
- DRUG
-
Chemotherapy for lymphodepletion
- DRUG
-
Chemotherapy for lymphodepletion
Sponsors & Collaborators
-
Allogene Therapeutics
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-23
- Primary Completion
- 2025-01-27
- Completion
- 2025-01-27
- FDA Drug
- Yes
Countries
- United States
Study Locations
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