Safety and Efficacy of RN1201 Injection as First-Line Treatment for Newly Diagnosed Multiple Myeloma

This is a single-arm, dose-escalation exploratory study evaluating the safety and efficacy of RN1201, a BCMA/CD19-targeted allogeneic CAR-T cell therapy, in patients with newly diagnosed multiple myeloma. Patients will receive lymphodepletion followed by a single infusion of RN1201. Primary endpoints include incidence and severity of treatment-emergent adverse events. Secondary endpoints assess response rate and minimal residual disease (MRD) status.

NCT Number	NCT07652138
Lead Sponsor	The First Affiliated Hospital of Soochow University
Conditions	Multiple Myloma, Newly Diagnosed Multiple Myeloma (NDMM)
Enrollment	18 participants
Start Date	2025-07-30
Primary Completion	2027-01-01 (estimated)
Study Completion	2027-11-30 (estimated)
Updated on ClinicalTrials.gov	2026-06-16