This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 CAR-T therapy for patients with CD7-positive relapsed or refractory T-ALL/LBL, and to evaluate the pharmacokinetics of CD7 CAR-T in patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
CAR-T cells
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China
Dose-limiting toxicity and Maximum Tolerated dose
The DLT is evaluated as the proportion of patients who experienced adverse events related to RD13-02 that meet the criteria for DLT events after the first infusion.
Time frame: Up to 28 days after CAR-T cells infusion
Overall response rate,ORR
The proportion of patients with CR (complete remission) /CRi (complete remission with incomplete blood count recovery); The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).
Time frame: Evaluate at 4, 8, and 12 weeks after CAR-T infusion
Overall response rate with MRD-negative,MRD-ORR
Proportion of patients achieving CR/CRi who is MRD-negative in bone marrow
Time frame: Up to 1 years after CAR-T infusion
Duration of remission,DOR
The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion
Time frame: Up to 1 years after CAR-T infusion
Event-free survival, EFS
The time from first achieving CR/CRi to relapse or death
Time frame: Up to 1 years after CAR-T infusion
The proportion of patients who receive hematopoietic stem cell transplantation
The proportion of patients who receive hematopoietic stem cell transplantation
Time frame: Up to 1 years after CAR-T infusion
Overall survival, OS
The time from CAR-T infusion to death due to any cause
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Time frame: Up to 1 years after CAR-T infusion