This is a single arm study to evaluate the safety and efficacy of CAR70-BCMA dual-target CAR-T cell therapy for relapsed and refractory plasma cell neoplasms.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Each subject will receive a single infusion of BCMA-CD70-CAR-T cells. A classic "3+3" dose escalation design will be employed.
General Hospital of Western Theater Command of PLA
Chengdu, Chengdu, China
RECRUITINGTo evaluate the safety of CAR70-BCMA dual-target chimeric antigen receptor T-cell therapy in patients with relapsed or refractory plasma cell neoplasms expressing CD70 and/or BCMA based on the incidence of treatment-emergent adverse events (AEs).
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: Up to 3 years
To evaluate the safety of CAR70-BCMA CAR-T cells in the treatment of relapsed or refractory plasma cell neoplasms positive for CD70/BCMA based on the determination of the maximum tolerated dose (MTD).
Incidence of dose-limiting toxicity (DLT)
Time frame: Up to 28 days after CAR-T treatment
To evaluate the efficacy of CAR70-BCMA CAR-T cells in the treatment of relapsed or refractory plasma cell neoplasms positive for CD70/BCMA based on the objective response rate (ORR).
Objective response rate (ORR) Description: For multiple myeloma (plasma cell neoplasms, plasma cell leukemia), the efficacy evaluation criteria refer to the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (2024 Revision). ORR includes the proportion of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), and minimal response (MR).
Time frame: Within 3 months following infusion of CAR70-BCMA CAR-T cells
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