Can vaccines help prevent cancer?
Primary Outcome Measures :
- Type and incidence of DLT, incidence and severity of treatment related AE, CRS and Neurotoxicity (Safety and tolerability) [ Time Frame: 2 years ]AE will be collected and graded according to ASTCT consensus(for Cytokine Release Syndrome, CRS and Immune Effector Cell-Associated Neurotoxicity Syndrome, ICANS) and CTCAE v5.0(for AE except CRS/ICANS)
Secondary Outcome Measures :
CAR copies of GC022F in peripheral blood, bone marrow, CSF and tumor tissue (amplification and persistence) [ Time Frame: 2 years ]GC022F CAR copies in peripheral blood, tumor tissue, bone marrow and CSF will be measured by qPCR in 2 years.
CAR cells of GC022F in peripheral blood, bone marrow and CSF (amplification and persistence) [ Time Frame: 2 years ]GC022F CAR cells in peripheral blood, bone marrow and CSF will be measured by FCM in 2 years.
Objective response rate (ORR) (efficacy) [ Time Frame: 3 months ]ORR will be calculated as the percents of patients who achieved CR or PR.
Duration of Response (DOR) (efficacy) [ Time Frame: 2 years ]DOR will be calculated as the time from the first assessment of CR or PR to the first assessment of relapse or death from any cause.
Progression-Free Survival (PFS) (efficacy) [ Time Frame: 2 years ]PFS will be calculated as the time from CAR-T infusion to disease progression or death from any cause (whichever occurs first).
Overall Survival (OS) (efficacy) [ Time Frame: 2 years ]OS will be calculated as the time from CAR-T infusion to death from any cause.