Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04093596
PHASE1

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

Sponsor: Allogene Therapeutics

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2019-09-23

Completion Date

2027-09

Last Updated

2023-08-14

Healthy Volunteers

No

Interventions

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.

Locations (11)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

City of Hope

Duarte, California, United States

Stanford Cancer Institute

Palo Alto, California, United States

Sarah Cannon/Colorado Blood Cancer Institute

Denver, Colorado, United States

Mayo Clinic

Rochester, Minnesota, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

St. David's South Austin Medical Center

Austin, Texas, United States

Texas Transplant Institute

San Antonio, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States