Clinical Trial for the Safety and Efficacy of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma
This is a single arm, open-label, single-center study. This study is indicated for newly diagnosed multiple myeloma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 40 patients will be enrolled. Primary objective is to explore the safety and efficacy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Each subject receive BCMA CAR T-cells by intravenous infusion
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGDose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time frame: Baseline up to 28 days after BCMA CAR T-cells infusion
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Time frame: Baseline up to 2 years after BCMA CAR T-cells infusion
Multiple Myeloma (MM), Overall response rate (ORR)
Assessment of ORR (ORR = sCR+CR+VGPR+PR+MR) at Month 6, 12, 18 and 24
Time frame: At Month 1, 3, 6, 12, 18 and 24
Complete response rate(CRR)
Proportion of subjects who achieved morphological complete response (CR) and complete response with hematologic incomplete recovery (CRi)
Time frame: Baseline up to 2 years after BCMA CAR T-cells infusion
Partial response Rate (PRR)
Proportion of subjects who achieved a partial response (PR)
Time frame: Up to 2 years after BCMA CAR T-cells infusion
Overall survival
Death from any cause from the beginning of cell transfusion
Time frame: Up to 2 years after BCMA CAR T-cells infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.