This is a single arm, open-label, single center study to evaluate the safety and efficacy of BCMA/CD19 CAR-T cells in patients with BCMA+,CD19+ relapsed or refractory multiple myeloma.
CD19 has been extensively evaluated as a therapeutic target for relapsed or refractory multiple myeloma by chimeric antigen receptor T cell therapy,this is a single arm, open-label, single center study to preliminary explore the safety, tolerability and cellular pharmacokinetics of Anti-BCMA and Anti-CD19 CAR-T cells in the treatment of relapsed or refractory multiple myeloma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Autologous BCMA CAR-T cells and CD19 CAR-T cells with average 1-5\*10\^6 cells/kg body weight,separately.
The First Affiliated Hospital of Nangchang University
Nanchang, Jiangxi, China
RECRUITINGOverall response rate (ORR)
Assessment of ORR (ORR = sCR+CR+VGPR+PR ) at 1 months of treatment
Time frame: 2 year
minimal residual disease(MRD)
Assessment of MRD negative overall response rate at 3 months of treatment
Time frame: 2 year
Progression-free survival (PFS)
Assessment of Progression-free survival (PFS) at 6 months of treatment
Time frame: 2 year
Overall survival (OS)
Assessment of overall survival (OS) at 6 months of treatment
Time frame: 2 year
Safety (incidence of adverse events defined as dose-limited toxicity)
Occurrence of study related adverse events defined as NCI CTCAE 4.0 \> grade 3 possibly, probably, or definitely related to study treatment.
Time frame: Study treatment until Week 24
Expression of CD19 CART cells
Expression of CD19 CART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR) and by flow cytometry.
Time frame: 2 year
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