This study is a open-label, single-center Phase 2 study to evaluate the efficacy and safety of BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCT. A total of 40 subjects will be enrolled into this study.
The study is a prospective, single-arm, single-centre, phase II study designed to evaluate the efficacy and safety of BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCT. Patients with detectable MRD after undergoing ASCT MRD will be enrolled in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Autologous BCMA-directed CAR-T cells, infusion intravenously at a target dose of 2-4 x 10\^6 anti-BCMA CAR+T cells/kg.
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
RECRUITINGSafety and Tolerability
The incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 2 year
MRD-negativity rate
Achieving undetectable MRD, as determined by NGF/NGS 3 months after CAR-T cell infusion
Time frame: 3 months after CAR-T cell infusion
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: 1 month after the CAR-T cell transfusion, after consolidation therapy
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
Overall Survival (OS)
Overall survival is measured from the date of diagnosis to the date of the participant's death.
Time frame: Up to 5 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.