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/AML, and to evaluate the pharmacokinetics of CD7 CAR-T in patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
CAR-T cells
Affiliated hospital of Xuzhou medical college
Xuzhou, Jiangsu, China
Overall response rate (ORR)
The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi) .
Time frame: Evaluate at 4 weeks after CAR-T infusion
Overall response rate, ORR
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) .
Time frame: Evaluate at 8 weeks after CAR-T infusion
Overall response rate, ORR
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) .
Time frame: Evaluate at 12 weeks after CAR-T infusion
Objective response rate , ORR
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and partial response (PR).
Time frame: Up to 1 years after CAR-T infusion
Overall response rate with Minimal Residual Disease (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 subjects who achieved remission after infusion who received Hematopoietic Stem Cell Transplantation (HSCT)
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
Time frame: Up to 1 years after CAR-T infusion
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