This is a single-arm, open-label, dose-escalation study to evaluate the safety, tolerability, cellular kinetics and initial efficacy of CAR-T cell therapy targeting GPRC5D in multiple myeloma subjects who have failed the standard treatments.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
After enrollment, subjects complete the PBMC apheresis, then complete the Lymphocyte clearance, and then receive the dose climbing test: 1×10e6/kg,3×10e6/kg,6×10e6/kg.
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China
Dose limited toxicity (DLT)
Dose limited toxicity
Time frame: From date of initial treatment to Day 28 post GPRC5D CAR-T infusion.
AE and SAE
Adverse event and serious adverse event
Time frame: From admission to the end of the follow-up, up to 2 years
Concentration of CAR-T cells
In peripheral blood and bone marrow
Time frame: From admission to the end of the follow-up, up to 2 years
Objective Response Rate, ORR
Proportion of subjects with complete or partial remission
Time frame: In 3 months of GPRC5D CAR-T cell infusion
Disease control rate, DCR
The percentage of patients with remission and stable disease after treatment in the total evaluable cases.
Time frame: From Day 28 GPRC5D CAR-T infusion up to 2 years
Duration of remission, DOR
The time from the first assessment of remission or partial remission of the tumor to the first assessment of disease progression or death from any cause;
Time frame: 24 months post GPRC5D CAR-T cells infusion
Progression-free survival, PFS
The time from cell reinfusion to the first assessment of tumor progression or death from any cause
Time frame: 24 months post GPRC5D CAR-Tcells infusion
Overall survival, OS
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The time from the cell reinfusion to death due to any cause.
Time frame: From GPRC5D CAR-T infusion to death,up to 2 years