This is a single arm, open label, multi-center prospective study to explory the safety and efficacy of GC012F CAR-T cells in patient diagnosed with high-risk chromosomal abnormalities BCMA+ multiple myeloma(MM).
The main aim of this study is to determin the safety and efficacy of GC012F in cytogenetic high-risk MM. GC012F is an autologus dual chimeric antigen receptor T-cell(CAR-T) therapy that targets B-cell maturation antigen(BCMA) and CD19. This study comprises of a screening phase(less than or equal to 28 days prior to apheresis) followed by apheresis(will occur upon enroiiment); Treatment Phase including autologus stem cell transplant on Day-1 followed by infusion of GC012F on Day0 and then post-infusion assessments from Day1 to Day 84; and a Post-treatment Phase(Day 85 and up to end of the study). Efficacy will be explored to assessed and safety will be closely monitored during the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
GC012F injection is a autologous dual CAR-T targeted BCMA and CD19. A single infusion of CAR-T cells will be administered intravenously.
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Incidence and severity of adverse events after GC012F injection
Time frame: Minimum 2 years after GC012F infusion
Percentage of MRD negative patients after GC012F infusion
Time frame: Minimum 2 years after GC012F infusion
ORR(PR, VGPR, CR and sCR) of patients after GC012F treatment
percent of subjects who achieving PR or better after GC012F infusion
Time frame: Minimum 2 years after GC012F infusion(Day0)
Progression free survival after GC012F treatment
Time frame: Minimum 2 years after GC012F infusion(Day0)
Duration of response of subjects after GC012F treatment
Time frame: Minimum 2 years after GC012F infusion(Day0)
Overall survivalof subjects after GC012F treatment
Time frame: Minimum 2 years after GC012F infusion(Day0)
Cytokines in serum after GC012F infusion
Time frame: Minimum 24 weeks after GC012F infusion(Day0)
Subset of lymphocytes in blood after GC012F infusion
Time frame: Minimum 2 years after GC012F infusion(Day0)
Anti-GC012F antibodies in blood after GC012F infusion
Time frame: Minimum 2 years after GC012F infusion(Day0)
Cell counts of GC012F in blood and bone marrow(if available) after GC012F infusion
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Time frame: Minimum 2 years after GC012F infusion(Day0)
Copies of GC012F in blood and bone marrow(if available) after GC012F infusion
Time frame: Minimum 2 years after GC012F infusion(Day0)