drugset / Trial / NCT07652138

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

NCT07652138 ↗

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2025-07-30
Primary completion
2027-01-01
Completion
2027-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject RN1201 Cell therapy — —

Indications