This is a single-arm, open-label study to evaluate the efficacy and safety of BCMA CAR-T in dynamic high-risk patients with multiple myeloma
The study is a prospective, single-arm, single-centre, phase II study designed to evaluate the efficacy and safety of BCMA CAR-T in dynamic high-risk patients with multiple myeloma. Patients received BCMA CAR-T cells infusion after standard FC lymphoma deletion therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Autologous BCMA-directed CAR-T cells, infusion intravenously at a target dose of 2.0-4.0 x 10\^6 anti-BCMA CAR+T cells/kg
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, China
RECRUITINGSafety and Tolerability
The incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 2 year
MRD-negative rate
achieving MRD-negative, as determined by NGS/NGF after consolidation treatment
Time frame: within 3 months after BCMA CAR-T infusion
Persistent MRD-negative rate
Persistent MRD-negative rate more than 12 months
Time frame: Up to 2 year
Progression free survival (PFS)
Progression free survival is defined as the time from the date of diagnosis to the date of first documented PD, as defined in the IMWG criteria, or death due to any cause, whichever occurs first
Time frame: Up to 2 year
Complete response rate (CRR)
CR or better is defined as percentage of participants who achieve a CR response or Stringent Complete Response (sCR) response accoording to the IMWG criteria
Time frame: within 3 month after the CAR-T cell transfusion
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