NCT03430011: Phase 1/2 - Autologous BCMA-specific CAR-T cells JCARH125 in RRMM (EVOLVE)

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

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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

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CART - BCMA : National Cancer Institute

Biological: JCARH125B

Anakinra

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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)

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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)

https://doi.org/10.1182/blood-2018-99-113548

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).

https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.8504

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- 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

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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