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

NCT07652138 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-06-16

No results posted yet for this study

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.

Conditions

  • Multiple Myloma
  • Newly Diagnosed Multiple Myeloma (NDMM)

Interventions

DRUG

BCMA/CD19-targeted allogeneic CAR-T

Lymphodepletion chemotherapy followed by allogeneic CAR-T cell (RN1201) infusion

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07652138 on ClinicalTrials.gov