About this trial
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。
Eligibility criteria
Qualifiers
Age 3-70
Diagnosis of r/r NK/T lymphoma.
CD7 positive expression
Bone marrow lymphoblasts ≥5% by morphologic evaluation at screening
Disqualifiers
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).
Trial design
Treatments tested in this trial
- RD13-02 cell infusion
Treatment groups
Sponsors and collaborators
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
Nanjing Bioheng Biotech Co., Ltd.
Collaborator