This is a phase I/II, open-label, multicenter study to assess the efficacy and safety of IM19 CAR-T cells in adult R/R Mantle Cell Lymphoma subjects
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
IM19 CAR-T cells will be administered at dose level: 100×10\^6 CAR-T cells or 200×10\^6 CAR-T cells
300 mg/m\^2 per day for 3 days (IV)
30 mg/m\^2 per day for 3 days (IV)
Incidence of adverse events (AEs) and abnormal laboratory test results as assessed by CTCAE V5.0
Time frame: Up to 28 days after IM19 CAR-T cell infusion
Objective response rate (ORR)
ORR, defined as the proportion of participants with a complete response or partial response, as determined by the investigator according to Lugano(2014)
Time frame: At 3 months after IM19 CAR-T cell infusion
Objective response rate (ORR)
ORR, defined as the proportion of participants with a complete response or partial response, as determined by the investigator according to Lugano(2014)
Time frame: At 28 days and 6 months after IM19 CAR-T cell infusion
Progression-free survival (PFS)
PFS, defined as the time from CAR-T cell infusion to the first occurrence of disease progression or death from any cause (whichever occurs first) , as determined by the investigator according to Lugano(2014)
Time frame: Up to 24 weeks after IM19 CAR-T cell infusion
Duration of Response (DOR)
DOR, defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first) in Stage 1, as determined by the investigator according to Lugano(2014)
Time frame: Up to 24 weeks after IM19 CAR-T cell infusion
Overall survival (OS)
OS , defined as the time from IM19 CAR-T cell infusion to death from any cause
Time frame: Up to 24 weeks after CAR-T cell infusion
Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The persistence over time of CAR T cells in the peripheral blood as determined by flow cytometry and qPCR
Time frame: Up to 24 weeks after IM19 CAR-T cell infusion
Anti-therapeutic IM19 CAR-T cells antibody
Time frame: Up to 24 weeks after IM19 CAR-T cell infusion