RN1201 Injection in Newly Diagnosed High-Risk Cytogenetic 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 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.

NCT Number	NCT07114432
Lead Sponsor	Tianjin Medical University Cancer Institute and Hospital Collaborators: Allorunning Therapeutics
Conditions	Newly Diagnosed High-Risk Cytogenetic Multiple Myeloma Patients Ineligible or Unwilling to Undergo ASCT, Newly Diagnosed Multiple Myeloma (NDMM)
Enrollment	19 participants
Start Date	2025-08
Primary Completion	2027-12 (estimated)
Study Completion	2028-08 (estimated)
Updated on ClinicalTrials.gov	2025-08-11