- Active, not recruiting
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
CART - BCMA : National Cancer Institute
Biological: JCARH125B</