NCT07114432

RN1201 Injection in Newly Diagnosed High-Risk Cytogenetic Multiple Myeloma

An Exploratory Clinical Study on the Safety and Efficacy of BCMA/CD19 Allogeneic CAR-T Cell Injection in Newly Diagnosed High-Risk Cytogenetic Multiple Myeloma Patients Ineligible or Unwilling to Undergo ASCT

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 1, single-arm, dose-escalation exploratory study to evaluate the safety, feasibility, and preliminary efficacy of RN1201, a BCMA/CD19-targeted allogeneic CAR-T cell therapy, in patients with newly diagnosed high-risk cytogenetic multiple myeloma (MM) who are ineligible or unwilling to undergo autologous stem cell transplantation (ASCT). Patients will receive lymphodepletion chemotherapy followed by a single infusion of RN1201 cells, across four dose levels. The primary endpoint will assess the incidence and severity of treatment-emergent adverse events (TEAEs), while secondary endpoints will evaluate the objective response rate (ORR), complete response (CR), minimal residual disease (MRD) status, and pharmacokinetics (PK) and pharmacodynamics (PD) of RN1201.

Conditions

• Newly Diagnosed High-Risk Cytogenetic Multiple Myeloma Patients Ineligible or Unwilling to Undergo ASCT
• Newly Diagnosed Multiple Myeloma (NDMM)

Interventions

Type	Name	Description
DRUG	BCMA/CD19-targeted allogeneic CAR-T	Lymphodepletion chemotherapy followed by allogeneic CAR-T cell (RN1201) infusion

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-12-01
• Completion: 2028-08-01
• First posted: 2025-08-11
• Last updated: 2025-08-11

Locations

2 sites across 1 country: China