This study is designed to evaluate the safety and efficacy of cord blood-derived CAR-NK019 in the treatment of refractory/relapsed central nervous system lymphoma.
This study is a single-center, open, single-arm incremental, exploratory study designed to evaluate the safety and efficacy of cord blood-derived CAR-NK019 in the treatment of refractory/relapsed central nervous system lymphoma. The study will be divided into two stages: Phase I is the dose escalation study, which is strictly based on the "3+3" dose escalation principle, and three dose groups are set up, which are administered through the ommaya capsule ventricle, and each dose is infused once a week for 3 weeks. Three to six subjects are intended to be enrolled in each dose group, with each subject observed for at least 28 days after receiving the initial infusion and a long-term follow-up period of two years after each infusion. Phase II is the dose expansion phase: The recommended dose and administration mode for this phase will be determined after comprehensive consideration based on safety data obtained in phase I, the proliferation and survival of CAR-NK cells in vivo, and clinical efficacy data, and 24 effective subjects will be recruited for further evaluation of efficacy and safety. Long-term follow-up lasted up to 2 years after the first CAR-NK transfusion in each patient.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
lentiviral vector-transducted cord blood-derived NK cells to express anti-CD19 CAR
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Incidence of dose limiting toxicity (DLTs)
To evaluate the safety, tolerability, and determine the recommended dosage of cord blood-derived Anti-CD19 CAR-NK Cell Therapy for refractory/relapsed central nervous system lymphoma
Time frame: Up to 28 days
Complete response rate (CR)
To determine the anti-tumor effectivity of CB CAR-NK019
Time frame: 3 months
Overall response rate (ORR)
To determine the anti-tumor effectivity of CB CAR-NK019
Time frame: 3 months
Progression free survival (PFS)
To determine the anti-tumor effectivity of CB CAR-NK019
Time frame: Up to 2 years
Overall survival (OS)
To determine the anti-tumor effectivity of CB CAR-NK019
Time frame: Up to 2 years
Duration of response (DOR)
To determine the anti-tumor effectivity of CB CAR-NK019
Time frame: Up to 2 years
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