The safety and preliminary effectiveness of CD147-CAR T cells in patients with relapsed or refractory T cell non-Hodgkin's lymphoma will be investigated in this pioneering study.
CD147 has been demonstrated higher and relatively specific expression on T cell non-Hodgkin's lymphoma. Preclinical studies have shown that CAR T cells targeting CD147 antigen can continuously eliminate Jurkat T-cell lymphoma in mice and extend survival without severe adverse events including hemolysis. Preliminary investigation of CD147-CAR T cells in solid tumors has started and shown an acceptable safety profile. The safety and preliminary effectiveness of CD147-CAR T cells in patients with relapsed or refractory T cell non-Hodgkin's lymphoma will be investigated in this pioneering study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
CAR T cells targeting CD147
Maximum tolerated dose (MTD)
The highest dose that does not cause unacceptable side effects.
Time frame: within 12 months
Dose-limiting toxicity (DLT)
Side effects serious enough to prevent an increase in dose.
Time frame: within 12 months
Adverse events
Adverse events
Time frame: within 12 months
Serious adverse events (SAE)
Serious adverse events (SAE)
Time frame: within 12 months
Adverse events of special interest (AESI)
Time frame: within 12 months
Overall response rate (ORR)
Overall response rate (ORR) evaluated according to the Lugano2014 criteria
Time frame: At the 12th week, 6th month, 9th month and 12th month
Complete response rate (CR)
Complete response rate (CR) evaluated according to the Lugano2014 criteria
Time frame: At the 12th week, 6th month, 9th month and 12th month
Duration of response (DOR)
Duration of response (DOR)
Time frame: At the 12th week, 6th month, 9th month and 12th month
Cmax of CD147-CAR T cells
Time frame: within 4 weeks
Xiaojun Huang, MD. PhD.
CONTACT
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Tmax of CD147-CAR T cells
Time frame: within 4 weeks
AUC of CD147-CAR T cells
Time frame: within 4 weeks