- Active, not recruiting
NCT04093596: Phase 1 - ALLO-715 BCMA Allogenic CAR T Cells in relapsed Multiple Myeloma (UNIVERSAL)
Updated: Feb 10
UNIVERSAL
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, or ALLO-647 alone.
Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)
Sponsor
Multiple locations
ClinicalTrials.gov Identifier: NCT04093596
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
First Posted : September 18, 2019
Click here for details on ClinicalTrials.gov
allogeneic anti-BCMA CAR-transduced T cells ALLO-715
ALLO-715 cells
alloCAR T ALLO-715
anti-BCMA allogeneic CAR T cells ALLO-715
BCMA allogeneic CAR T cells ALLO-715
ALLO 715
Nirogacestat (Code C82383)
Nirogacestat
NIROGACESTAT
PF-03084014
gamma secretase inhibitor PF-03084014
Universal: An Allogeneic First-in-Human Study of the Anti-Bcma ALLO-715 and the Anti-CD52 ALLO-647 in Relapsed/Refractory Multiple Myeloma
ASH :653. Myeloma/Amyloidosis: Therapy, excluding Transplantation|
November 5, 2020
Program: Oral and Poster Abstracts
651 Universal Updated Phase 1 Data Validates the Feasibility of Allogeneic Anti-BCMA ALLO-715 Therapy for Relapsed/Refractory Multiple Myeloma
Program: Oral and Poster Abstracts
Type: Oral
Session: 704. Cellular Immunotherapies: Allogeneic CARs and CARs for T Cell Lymphomas
Hematology Disease Topics & Pathways:
Cytokine Release Syndrome, Clinical Trials, Biological, Adults, Neurotoxicity, Clinical Research, Chimeric Antigen Receptor (CAR)-T Cell Therapies, Immunology, Cell Expansion, Diseases, Therapies, Adverse Events, Gene Editing, Myeloid Malignancies, Biological Processes, Technology and Procedures, Study Population
Monday, December 13, 2021: 11:00 AM
Conclusions
UNIVERSAL demonstrates proof of concept for allogeneic CAR T therapy in multiple myeloma. ALLO-715 showed CAR T cell dose response relationship with higher doses (DL3/DL4) leading to clinically meaningful efficacy, including high VGPR+ rate of 38.5% and high MRD negativity without requiring leukapheresis or bridging therapy.
ALLO-715 following LD with FCA has a tolerable safety profile. FCA induces a deep and durable window of lymphocyte depletion allowing CAR T cell expansion and persistence.
Learn more:
SOUTH SAN FRANCISCO, Calif., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer today announced that it will present updated data from its blood cancer portfolio at the 63rd Annual Meeting of the American Society of Hematology (ASH) taking place December 11 – 14, 2021. Allogene will have two oral presentations, one focused on the Phase 1 ALPHA2 study of ALLO-501A in large B-cell lymphoma (LBCL) and one on the Phase 1 UNIVERSAL single dose cohorts of ALLO-715 in relapsed/refractory multiple myeloma (MM). The Company will also present data on the Phase 1 ALPHA study of ALLO-501 in relapsed/refractory non-Hodgkin’s lymphoma (NHL) during a poster session. Updated data will be included in the oral and poster sessions on December 13, 2021.
- ALLO-715
- California: City of Hope Duarte
- Colorado: Sarah Cannon/Colorado Blood Cancer Institute Denver
- Massachusetts: Massachusetts General Hospital Boston
- Minnesota: Mayo Clinic Rochester Minnesota
- New York: Memorial Sloan-Kettering Cancer Center New York
- Wisconsin: Medical College Of Wisconsin Milwaukee
Location
United States, Arizona
United States, California
United States, Colorado
United States, Massachusetts
United States, Minnesota
United States, New York
United States, Ohio
United States, Tennessee
United States, Texas
United States, Wisconsin