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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Lymphodepletion chemotherapy followed by allogeneic CAR-T cell (RN1201) infusion
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGThe incidence and severity of treatment-emergent adverse events (TEAEs) and doselimiting toxicities (DLTs)
Time frame: DLTs: Within 28 days after CAR-T cell infusion; TEAEs: From infusion up to 24 months post-treatment.
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)
Time frame: 4 weeks, 3 months, 6 months, and 12 months
Pharmacokinetic (PK) of RN1201
Levels of RN1201 CAR-positive T cells in the blood and/or bone marrow
Time frame: Up to 52 weeks
Pharmacodynamic (PD) of RN1201
Levels of Peripheral blood M protein
Time frame: Up to 52 weeks
Pharmacodynamic (PD) of RN1201
Levels of urine M protein
Time frame: Up to 52 weeks
Pharmacodynamic (PD) of RN1201
Levels of Peripheral blood cytokines
Time frame: Up to 52 weeks
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