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

Trial Details

NCT ID
NCT07652138
Phase
PHASE1
Sponsor
The First Affiliated Hospital of Soochow University
Status
RECRUITING
Cancer Type
Newly Diagnosed Multiple Myeloma
Interventions
  • BCMA/CD19-targeted allogeneic CAR-T
Locations (sample)
  • Suzhou, Jiangsu, China|31.30408,120.59538

Key Eligibility Criteria

  • Willingness to participate in the trial and provide written informed consent.
  • 2\. Diagnosis of multiple myeloma (MM) per the 2017 revised WHO criteria.
  • 3\. BCMA-positive multiple myeloma documented at screening or in prior medical records.
  • 4\. Aged 18 - 70 years, any gender.

For full eligibility, visit ClinicalTrials.gov.

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