This is a multi-center, open-label, non-randomized, single-arm clinical trial. Refractory/relapse T-NHL patients are treated with autologous and allogeneic CD5 CAR T-cell therapy. The primary objective is to prospectively evaluate the safety of CD5 CAR T cell bridging to HSCT in the treatment of r/r T-NHL. The primary endpoint is the type and incidence of dose limiting toxicity (DLT) within 21 days after CD5 CAR-T cell infusion. A total of 36 subjects is estimated to be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Approximately 3-5 days prior to CD5 CAR-T cell infusion, subjects are treated with FC regimen (fludarabine and cyclophosphamide) for lymphodepletion. CAR-T cell infusion are performed 48 h after completion of chemotherapy.
Beijing GoBroad Hospital
Beijing, China
RECRUITINGRuijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
RECRUITINGShanghai Liquan Hospital
Shanghai, China
RECRUITINGDose-limiting toxicity (DLT)
Incidence and type of dose-limiting toxicity(DLT) within 21 days of CD7 CAR-T infusion.
Time frame: 21 days
Adverse events (AEs)
Total number, incidence and severity of adverse events (AEs) within 21 days of CD7 CAR-T infusion.
Time frame: 21 days
Objective Response Rate (ORR)
The assessment of ORR by dose group at 21 and 90 Days after CD7 CAR T infusion.
Time frame: 21, 90 days
Duration of response (DOR)
DOR is defined as the date when CR response criteria are first met to the date of relapse or death caused by T-NHL in the absence of documented relapse
Time frame: up to 2 years
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