1. Objective to evaluate the safety and tolerability of CAR19-BCMA dual-target CAR-T in the treatment of relapsed / refractory multiple myeloma. 2. To determine the maximum tolerated dose (MTD) of car19-bcma dual target car-t in the treatment of relapsed / refractory multiple myeloma.
This study is an open, single arm, prospective, phase I clinical study, using "3+3" dose escalation to explore the safety, maximum tolerated dose, in vivo pharmacokinetic characteristics and preliminary efficacy of CAR19-BCMA dual-target CAR-T cell injection in the treatment of relapsed / refractory multiple myeloma subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
This drug is CAR-T cell injection. CAR-T cells are based on the traditional CAR-T treatment, using cytokine combination amplification and improved transfection technology to change the activation mode of T cells.
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGIncidence and Severity of Adverse Events
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: in 3 months after CART infusion
Laboratoty tests
Abnormal results of laboratoty tests
Time frame: in 3 months after CART infusion
Overall response rate (ORR)
Percentage of subjects who achieved minimal response (MR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by the investigators
Time frame: Day28, Month2, Month3, Month6, Month12, Month18, Month24 after CAR-T infusion
Minimal Residual Disease (MRD) negative rate
Proportion of subjects who achieved MRD negative
Time frame: Day28, Month2, Month3, Month6, Month12, Month18, Month24 after CAR-T infusion
Overall Survival (OS)
Time from CAR19-BCMA CAR-T infusion to time of death due to any cause
Time frame: Minimum of 2 years post CAR-T infusion
Progression-free Survival (PFS)
Time from CAR19-BCMA CAR-T infusion to first documentation of progressive disease (PD), or death due to any cause, whichever occurs first
Time frame: Minimum of 2 years post CAR-T infusion
Event-free Survival (EFS)
Time from CAR19-BCMA CAR-T infusion to time of disease progression, recurrence, death, etc
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Time frame: Minimum of 2 years post CAR-T infusion
Disease Control Rate (DCR)
disease control rate after CAR19-BCMA CAR-T infusion
Time frame: at Day28, Month2, Month3 , Month6, Month12, Month18, Month24 after CAR-T infusion