Exploring CAR-GPRC5D Therapy for Adults 18 to 75 with Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia

What this Trial Is About

Researchers are evaluating the safety and effects of different doses of CAR-GPRC5D, a gene-modified T-cell therapy, in adults with relapsed or refractory multiple myeloma or plasma cell leukemia. This phase 1, single-center, open-label study focuses on patients who have undergone multiple previous treatments and have evidence of GPRC5D expression on their cancer cells. Participants will undergo apheresis to collect cells to manufacture the CAR-GPRC5D therapy. Before receiving the treatment, patients may have bridging therapy and will undergo lymphodepletion with fludarabine and cyclophosphamide for three days. Then, they will receive a single infusion of CAR-GPRC5D at one of three dose levels 1.0, 2.0, or 3.0 million CAR-T cells per kg. After infusion, patients will be monitored for at least two years, with long-term safety follow-up up to 15 years. Throughout the study, participants will have regular assessments including monitoring for side effects and adverse events, measuring disease response, and evaluating quality of life. Laboratory tests will track immune cell levels, drug presence, and related biomarkers. Researchers will observe outcomes such as dose-limiting toxicities, response rates, survival, and progression-free survival to understand the therapys impact over time.

A Study of CAR-GPRC5D in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia