University of Alabama, Birmingham, Alabama, United States
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.
This study will provide long-term follow-up for patients who have received treatment with a
Juno CAR T-cell product in a Juno-sponsored clinical trial. In this study, patients will be
followed for up to 15 years after their last dose of Juno CAR T cells for evaluation of
delayed adverse events, presence of persisting CAR T-cell vector sequences, presence of
replication-competent retrovirus (RCR) or lentivirus (RCL), and survival.