This is a multi-center, open-label, non-randomized, single-arm clinical trial. Refractory/relapse T-NHL patients are treated with autologous and allogeneic CD7 CAR T-cell therapy. The primary objective is to prospectively evaluate the safety of CD7 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 CD7 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 CD7 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, Beijing Municipality, China
RECRUITING湛江中心人民医院
Zhanjiang, Guangdong, China
RECRUITINGRuijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Dose-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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Shanghai Liquan Hospital
Shanghai, Shanghai Municipality, China
RECRUITING