A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19 CAR NK cells in patients with B-cell Non Hodgkin Lymphoma. 9-12 patients are planned to be enrolled in the dose-escalation trial (6×10\^8 cells, 1×10\^9 cells, 1.5×10\^9 cells). The primary endpoints are DLT, MTD. The secondary endpoints are the overall response rates (ORR) and disease control rate (DCR).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Patients will receive Fludarabine (30 mg/m2 per day) and Cyclophosphamide (300mg/m2 per day) on day -5, -4, and -3. Doses of 6×10\^8, 1×10\^9, 1.5×10\^9 Anti-CD19 CAR NK cells will infused in each group using the "3 + 3" dose-escalation strategy.
Changhai Hospital
Shanghai, China
RECRUITINGIncidence of dose limiting toxicity (DLTs)
To characterize the safety, tolerability, and determine the Maximum tolerated dose (MTD) of Anti-CD19 CAR NK Cells for Relapsed/Refractory diffuse large B cell lymphoma.
Time frame: within 4 weeks after infusion
Incidence of Treatment Emergent Adverse Events (TEAEs)
To characterize the safety of Anti-CD19 CAR NK Cells for Relapsed/Refractory diffuse large B cell lymphoma
Time frame: up to 48 weeks after infusion
The overall response rate (ORR)
To characterize the efficacy of Anti-CD19 CAR NK Cell Therapy for Relapsed/Refractory diffuse large B cell lymphoma
Time frame: 1, 3, 6 and 12 months after infusion
Disease control rate (DCR)
To characterize the efficacy of Anti-CD19 CAR NK Cell Therapy for R/R Non-Hodgkin Lymphoma.
Time frame: 1, 3, 6, 12 and 12 months after infusion
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