NCT04093596

Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)

A Single-Arm, Open-Label, Phase 1 Study of the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-715 to Evaluate an Anti-BCMA Allogeneic CAR T Cell Therapy With or Without Nirogacestat in Subjects With Relapsed/Refractory Multiple Myeloma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Allogene Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Relapsed/Refractory Multiple Myeloma

Interventions

Type	Name	Description
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	Fludarabine	Chemotherapy for lymphodepletion
DRUG	Cyclophosphamide	Chemotherapy for lymphodepletion
DRUG	Nirogacestat	a small molecule, selective, reversible, noncompetitive inhibitor of γsecretase (GSI) that increases BCMA target density on the surface of multiple myeloma cells.

Timeline

• Start date: 2019-09-23
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2019-09-18
• Last updated: 2023-08-14

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study