Study of Allogeneic CD19 and BCMA CAR-T Cell Therapy for Adults with Relapsed or Refractory B-cell or Plasma Cell Tumors Early Phase 1 Trial to Assess Safety and Effectiveness of RN1101 Treatment

What this Trial Is About

Researchers are evaluating the safety and effectiveness of an investigational treatment called RN1101, which are allogeneic CAR-T cells targeting CD19 and BCMA. This early-phase, open-label pilot study focuses on patients with relapsed or refractory B-cell or plasma cell-derived malignant tumors, including B-cell lymphoma and multiple myeloma. The study plans to enroll 21 patients to understand how well this treatment works and its safety profile for these challenging cancers. Participants will receive a single intravenous infusion of RN1101 cells designed to target and attack cancerous B cells or plasma cells. The study involves a dose-escalation approach where all patients receive the experimental therapy. Researchers will monitor the treatments ability to reduce or eliminate cancer cells expressing CD19 or BCMA and evaluate how long these CAR-T cells persist in the body. Throughout the study, participants will be closely followed for up to 24 weeks after the infusion. Researchers will assess safety by tracking adverse events and measure effectiveness using outcomes such as minimal residual disease status, response rates, progression-free survival, overall survival, and CAR-T cell presence in blood and bone marrow. Blood tests, imaging, and clinical evaluations will be performed regularly to monitor treatment response and participant health over this period.

A Clinical Study of Allogeneic CD19/BCMA CAR-T Cells for the Treatment of R/R B-cell Malignant Tumors