Study of CAR-GPRC5D T Cell Therapy for Adults Aged 18 to 75 With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia

What this Trial Is About

Researchers are evaluating the safety and effectiveness 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, open-label study focuses on patients who have already received multiple prior treatments. The trial aims to understand how well these modified T cells work and how safe they are for this patient group. Participants will undergo apheresis to collect their cells, which are then modified to create CAR-GPRC5D T cells. Before receiving the therapy, patients undergo lymphodepletion with fludarabine and cyclophosphamide for three days. They will then get a single infusion of CAR-GPRC5D at one of three dose levels. Bridging therapy is allowed between cell collection and lymphodepletion. After treatment, participants will be followed for at least two years, with long-term safety monitoring up to 15 years. During the study, patients will be closely monitored for side effects and treatment responses. Researchers will assess adverse events, response rates, survival, and quality of life. They will also track the therapys presence and activity in the body and evaluate immune system markers. The study involves regular visits, lab tests, and assessments over the follow-up period to gather comprehensive safety and effectiveness data.

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