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Safety and Efficacy of RN1201 Injection as First-Line Treatment for Newly Diagnosed Multiple Myeloma
Sponsor: The First Affiliated Hospital of Soochow University
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.
Official title: An Exploratory Clinical Study on the Safety and Efficacy of RN1201 Injection as First-Line Treatment for Newly Diagnosed Multiple Myeloma
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2025-07-30
Completion Date
2027-11-30
Last Updated
2026-06-16
Healthy Volunteers
No
Interventions
BCMA/CD19-targeted allogeneic CAR-T
Lymphodepletion chemotherapy followed by allogeneic CAR-T cell (RN1201) infusion
Locations (1)
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China