This is a single-arm, single-center, open-label clinical study to evaluate the safety and efficacy of CAR-T in patients with NDMM.
9-18 evaluable subjects are planned to be enrolled in this study. Apheresis will be carried out in subjects who meet eligible criteria, and total 2 cycles of induction therapy (three-drug combination regimen based on bortezomib with details determined by the investigator according to the patient's condition) will be selectively given to subjects before or after apheresis. Next, subjects will receive a single infusion of CAR-T, and the efficacy assessments will be performed at 1st month, 3rd months, and every 3 months within 2 years until the end of the trial (MRD testing is required for each efficacy assessment) 1.Efficacy assessments performed at the 1st month after infusion: 1. \<PR: Protocol change or follow-up decided by the investigator. 2. ≥PR: Follow-up. 2.Efficacy assessments performed at the 3rd month after infusion and every 3 months thereafter: 1. \<VGPR: Protocol change or follow-up decided by the investigator. 2. ≥VGPR: Maintenance treatment using lenalidomide until progress disease or clinical trial intolerance or termination of trial. After signing the informed consent form (ICF), subjects will be followed up for efficacy and safety until 2 years after CAR-T infusion, or disease progression, or death, or withdrawal of consent, or any intolerable toxicity, whichever comes first. All AEs in subjects, especially infection related symptoms and signs, will be closely monitored during follow-up, and prophylactic treatment will be administered according to clinical practice when necessary. In case of disease progression within 2 years after CAR-T infusion, treatment will be administered according to clinical practice, and the survival follow-up (only for the survival status) will be performed every 12 weeks±14 days (2 weeks) until 2 years after infusion, or death, or withdrawal of consent, whichever comes first. For subjects who have undergone transportation or any other clinical routine treatments after CAR-T infusion, survival follow-up will be also performed as described above.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
GC012F injection is an 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
RECRUITINGAdverse Events (AE) after CAR-T infusion
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), with the exception of cytokine release syndrome (CRS), and immune effector cellassociated neurotoxicity syndrome (ICANS). CRS and ICANS should be evaluated according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading
Time frame: Up to 1 year after patients infused with CAR-T injection
Percentage of patients with complete response (CR) and stringent complete response (sCR) after infusion
Time frame: Up to 2 years after patients infused with CAR-T injection
overall response rate (ORR)
ORR defined as proportion of patients achieving PR or better based on IMWG defined response criteria
Time frame: Up to 2 years after patients infused with CAR-T injection
Percentage of patients with minimal residual disease (MRD) negative in CR/sCR patients at landmark analysis
MRD negative rate
Time frame: Up to 2 years after patients infused with CAR-T injection
Progress free survival (PFS)
PFS is defined as the time interval from the initiation of induction therapy until disease progression or death (for any reason).
Time frame: Up to 2 years after patients infused with GC01 2F injection
Duration of response (DOR) after CAR-T infusion
DOR is defined as the time interval from the first assessment of sCR, CR, VGPR or PR to the first assessment of PD or death from any cause after CAR T infusion.
Time frame: Up to 2 years after patients infused with GC01 2F injection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.