Actively Recruiting
Phase 1 Study of BCMA-CD19 cCAR T Cell Therapy for Patients with Relapsed or Refractory Multiple Myeloma and Plasmacytoid Lymphoma
Led by iCell Gene Therapeutics · Updated on 2025-09-16
12
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of BCMA-CD19 cCAR, a new type of immunotherapy, in patients with relapsed or refractory multiple myeloma and plasmacytoid lymphoma. This phase I, single-arm, open-label study investigates a compound Chimeric Antigen Receptor cCAR therapy designed to target two proteins, BCMA and CD19, on cancer cells. The treatment aims to address the challenges of tumor heterogeneity and resistance in these diseases by attacking both myeloma and lymphoma cells with dual-targeted CAR T-cells. The treatment involves administering BCMA-CD19 cCAR T cells, which are genetically modified T cells expressing receptors against BCMA and CD19. These cells are given intravenously after patients receive lymphodepleting chemotherapy. The study includes a dose escalation phase, starting from 2 million to 10 million CAR T cells per kilogram of body weight, to find the most suitable dose. Both fresh and thawed CAR T cells may be used during infusion. Participants will be closely monitored for adverse events, especially within the first 28 days after infusion and up to two years. Researchers will track treatment-emergent side effects for up to six months. The study requires informed consent and involves assessments of safety and tolerability. Overall participation duration and follow-up visits will ensure careful evaluation of the treatments effects over time.
CONDITIONS
Brief Title
BCMA-CD19 cCAR in Multiple Myeloma and Plasmacytoid Lymphoma
Research Team
K
Kevin Pinz, MS
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