This is a single arm study to evaluate the safety and efficacy of CAR BCMA-CD70 CAR-T cell therapy for high-risk plasma cell neoplasms.
The subject or their legally acceptable representative has provided written informed consent and is willing and able to comply with all scheduled study visits, study treatment administration, laboratory tests, and other required trial procedures.
Deletion of the short arm of chromosome 17 (del(17p)) with clonal proportion ≥ 20%, and/or TP53 gene mutation;
IgH translocation (t(4;14), t(14;16), or t(14;20)) combined with 1q amplification (1q+) and/or deletion of the short arm of chromosome 1 (del(1p32));
Chromosome 1 abnormalities: monoallelic del(1p32) plus 1q+, or biallelic del(1p32);
Severe cardiac insufficiency with left ventricular ejection fraction (LVEF%) < 50%.
History of severe chronic lung disease associated with impaired pulmonary function.
Concurrent active or progressive malignant tumors other than the target plasma cell neoplasm.
Concurrent severe infection that cannot be effectively controlled with standard therapy.
Single group
CAR BCMA-CD70-T cells
GeneticEach subject will be infused with single dose of BCMA-CD70-CAR-T cells. A classic "3+3" dose escalation will be employed. The low dose is 1×10\^6 /kg, the medium dose is 2×10\^6 /kg, and the high dose is 3×10\^6 /kg.
fludarabine and cyclophosphamide
DrugDescription: Drug: Fludarabine Fludarabine will be given at a dose of 30 mg/m2/day intravenously (IV) for 3 days prior to the infusion of BCMA-CD70-CAR-T cells. Drug: Cyclophosphamide Cyclophosphamide will be given at a dose of 300 mg/m2/day intravenously (IV) for 3 days prior to the infusion of BCMA-CD70-CAR-T cells.
According to the incidence of treatment-related adverse events (AEs) to evaluate the safetyof CAR BCMA-CD70 CAR-T cells in the treatment of CD70/BCMA positive high-risk plasma cell neoplasms.
Incidence of treatment-related adverse events (AEs) Description: Number and severity of adverse events graded according to CTCAE v5.0, including cytokine release syndrome (CRS) graded by ASTCT criteria and immune effector cell-associated neurotoxicity syndrome (ICANS) graded by ASBMT criteria
According to the determine the Maximal Tolerable Dose(MTD) to evaluate the safety of CAR BCMA-CD70 CAR-T cells in the treatment of CD70/BCMA positive high-risk plasma cell neoplasms.
According to the objective response rate (ORR) to evaluate the efficacy of CAR BCMA-CD70 CAR-T cells in the treatment of CD70/BCMA positive high-risk plasma cell neoplasms.
Overall response rate (ORR) Description: Multiple myeloma (plasma cell neoplasms, plasma cell leukemia) refers to the efficacy evaluation criteria in the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (revised in 2024),ORR includes strictly defined proportions of complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), and minimal response (MR).
According to the pharmacokinetics (number of CAR-T cells in peripheral blood was measured to evaluate the persistence of CAR-T cells) to explore the kinetics and clonal evolution of CAR BCMA-CD70 CAR-T cells.
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