This is a single arm, open-label, multi-center prospective study to determine the safety and efficacy of GC012F CAR-T cells in patients diagnosed with BCMA+ refractory/relapsed multiple myeloma (r/r MM).
The main aim of the study is to determine the safety and efficacy of GC012F in r/r MM. GC012F is an autologous 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 enrollment); Treatment Phase including a conditioning regimen followed by infusion of GC012F and post-infusion assessments from Day 1 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 CART cells will be administered intravenously.
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGIncidence and severity of adverse events after GC012F infusion
Time frame: up to 24 weeks after GC012F infusion
Percentage of MRD negative patients after GC012F treatment
Time frame: 12 weeks, 24 weeks after GC012F infusion
ORR (PR, VGPR, CR and sCR) of patients receive GC012F treatment
Time frame: 12 weeks, 24 weeks after GC012F infusion
Progression free survival after GC012F treatment
Time frame: 12 weeks, 24 weeks after GC012F infusion
Copies and cell counts of CAR in blood and bone marrow (if available) after GC012F treatment
Bone marrows will be collected in weeks 4, 8, 12, 18, 24 after GC012F infusion.
Time frame: Days 4, 7, 10, 14 and weeks 4, 8, 12, 18, 24 after GC012F infusion
Cytokines in serum after GC012F treatment
Time frame: Days 4, 7, 10, 14 and weeks 4, 8, 12, 18, 24 after GC012F infusion
Subset of lymphocytes and ADA in blood after GC012F treatment
Time frame: Weeks 4, 8, 12, 18, 24 after GC012F infusion
Replication competent lentivirus (RCL) in blood after GC012F treatment
Time frame: Weeks 4, 12, 24 after GC012F infusion
Duration of response after GC012F treatment
Time frame: 12 weeks, 24 weeks after GC012F infusion
Overall survival after GC012F treatment
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Time frame: 12 weeks, 24 weeks after GC012F infusion