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.
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.
Patients with serious active infections.
2. Subjects with acquired or congenital immunodeficiency.
3. Subjects with Class III/IV heart failure per NYHA criteria.
4. Subjects with epilepsy or other central nervous system diseases.
Single group
BCMA/CD19-targeted allogeneic CAR-T
DrugLymphodepletion chemotherapy followed by allogeneic CAR-T cell (RN1201) infusion
The incidence and severity of treatment-emergent adverse events (TEAEs) and doselimiting toxicities (DLTs)
Overall effectiveness and duration of efficacy
Overall response rate (ORR) and complete response rate (CR), negative rate of MRD (detected by flow cytometry or NGS)
Pharmacokinetic (PK) of RN1201
Levels of RN1201 CAR-positive T cells in the blood and/or bone marrow
Pharmacodynamic (PD) of RN1201
Levels of Peripheral blood M protein
Pharmacodynamic (PD) of RN1201
Levels of urine M protein
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