This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 Chimeric Antigen Receptor-T(CAR-T) therapy for patients with CD7-positive relapsed or refractory natural killer/T cell lymphoma, and to evaluate the pharmacokinetics of CD7 CAR-T in patients。
Age 3-70
Diagnosis of r/r NK/T lymphoma.
CD7 positive expression
Bone marrow lymphoblasts ≥5% by morphologic evaluation at screening
Subjects with concomitant genetic syndromes associated with bone marrow failure states.
Isolated extramedullary lesions
Subjects with some cardiac conditions will be excluded.
With uncontrolled active central nervous system leukemia (CNSL), cerebrospinal fluid grade Central Nervous System3(CNS3).
Single group
RD13-02 cell infusion
DrugCAR-T cells
Overall response rate (ORR)
The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi)
Duration of remission (DOR)
The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion
Event-free survival (EFS)
The time from first achieving CR/CRi to relapse or death
Overall survival (OS)
The time from CAR-T infusion to death due to any cause
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
Nanjing Bioheng Biotech Co., Ltd.
Collaborator
