drugset / Trial / NCT07114432

RN1201 Injection in Newly Diagnosed High-Risk Cytogenetic Multiple Myeloma

NCT07114432 ↗

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 cytogenetically high-risk multiple myeloma who are ineligible or unwilling to undergo autologous stem cell transplantation (ASCT). Patients will receive lymphodepletion followed by a single infusion of RN1201 across four dose levels. Primary endpoints include incidence and severity of treatment-emergent adverse events. Secondary endpoints assess response rate and minimal residual disease (MRD) status.

Timeline

Start
2025-08
Primary completion
2027-12
Completion
2028-08

Drugs

EvaluationDrugModalityDoseRoute
Subject RN1201 Cell therapy — —

Indications