NCT03430011: Phase 1/2 - Autologous BCMA-specific CAR-T cells JCARH125 in RRMM (EVOLVE)
Updated: May 27, 2022
EVOLVE
Autologous BCMA-specific CAR-T cells JCARH125
NCT03430011: Phase 1/2 - Study Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed and/or Refractory Multiple Myeloma (EVOLVE)
This is an open-label, multicenter, Phase 1/2 study to determine the safety and efficacy of JCARH125, a CAR T-cell product that targets B-cell maturation antigen (BCMA), in adult subjects with relapsed and/or refractory multiple myeloma. The study will include a Phase 1 part to determine the recommended dose of JCARH125 in subjects with relapsed and/or refractory multiple myeloma, followed by a Phase 2 part to further evaluate the safety and efficacy of JCARH125 at the recommended dose.
The safety and tolerability of JCARH125 in subjects who receive prophylactic treatment with anakinra will be evaluated in a separate Phase 1 cohort. The antitumor activity of JCARH125 in subjects who have been previously treated with BCMA-directed therapy will be evaluated in separate Phase 2a cohorts.
Sponsor
Juno Therapeutics, a Subsidiary of Celgene
ClinicalTrials.gov Identifier: NCT03430011
Official Title: Protocol H125001: An Open-Label Phase 1/2 Study of JCARH125, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed or Refractory Multiple Myeloma
First Posted : February 12, 2018
Click here for details on Clinicaltrials.gov
Biological: JCARH125B
autologous anti-BCMA CAR-T cells JCARH 125
autologous BCMA 41BBz CAR-T cells JCARH-125
autologous BCMA-specific CAR-T cells JCARH125
autologous BCMA-specific CAR4-1BB-CD3zeta-expressing CD4+/CD8+ T lymphocytes JCARH 125
anakinra ( IL-1ra interleukin-1 receptor antagonist)
653. Myeloma: Therapy, excluding Transplantation: Immunotherapies in Plasma Cell Disorders| November 29, 2018
JCARH125, Anti-BCMA CAR T-cell Therapy for Relapsed/Refractory Multiple Myeloma: Initial Proof of Concept Results from a Phase 1/2 Multicenter Study (EVOLVE)
Meeting Abstract | 2020 ASCO Annual Meeting I
Journal of Clinical Oncology > Volume 38, Issue 15_suppl
Orvacabtagene autoleucel (orva-cel), a B-cell maturation antigen (BCMA)-directed CAR T cell therapy for patients (pts) with relapsed/refractory multiple myeloma (RRMM): update of the phase 1/2 EVOLVE study (NCT03430011).
- Alabama: University of Alabama at Birmingham
- California: City of Hope Duarte
- California: University of California San Francisco
- Colorado: Sarah Cannon/Colorado Blood Cancer Institute Denver
- Georgia: Emory University Atlanta
- Illinois: University of Chicago
- Maryland: Johns Hopkins Baltimore
- Massachusetts: Massachusetts General Hospital Boston
- Minnesota: Mayo Clinic Rochester Minnesota
- New Jersey: Hackensack University Medical Center
- New York: Memorial Sloan-Kettering Cancer Center New York
- New York: Roswell Park Cancer Institute Buffalo
- Washington: Fred Hutchinson Cancer Center Seattle
- Washington: Swedish Cancer Inst Seattle
Locations
United States, Alabama
United States, California
United States, Colorado
United States, Georgia
United States, Illinois
United States, Kansas
United States, Maryland
United States, Massachusetts
United States, Michigan
United States, Minnesota
United States, New Jersey
United States, New York
United States, Oregon
United States, Texas
United States, Washington
United States, Wisconsin