Phase 1 Study of OriV508 Injection for Safety and Early Effectiveness in Adults with Relapsed or Refractory Multiple Myeloma and Aggressive B-cell Non-Hodgkin Lymphoma

What this Trial Is About

Researchers are evaluating OriV508 injection, a drug using a self-inactivating lentiviral vector that carries a BCMACD19 dual-target CAR, for patients with relapsed or refractory B-cell hematological malignancies such as multiple myeloma and aggressive B-cell non-Hodgkin lymphoma. This early phase 1, single-center, open-label study focuses on assessing safety, tolerability, preliminary efficacy, and immune response in these patients who have undergone prior treatments without success. The study involves administering OriV508 intravenously to produce BCMACD19 CAR-T cells in the body. It uses a dose-escalation approach to carefully evaluate how patients tolerate the treatment. Participants receive the injection followed by monitoring for adverse effects and immune responses over a treatment period that may last up to 96 weeks. The study is single-arm and does not include a placebo or comparison group. Participants will undergo evaluations including safety assessments for dose-limiting toxicities, cytokine release syndrome, neurotoxicity, and other adverse effects from infusion up to 96 weeks after treatment. Researchers will also measure overall and complete response rates, duration and time to response, survival outcomes, minimal residual disease, and CAR-T cell kinetics through blood tests and clinical visits during the study. The total participation time may extend up to nearly three years, allowing for long-term follow-up and comprehensive monitoring.

An Open-label, Single-arm Clinical Study to Evaluate the Safety and Preliminary Efficacy of OriV508 Injection in Treating Relapsed/Refractory Hematological Malignancies