To study the safety and effectiveness of cord blood-derived IL-10/IL-15 CD19-CAR NK in patients with B-cell non-Hodgkin's lymphoma
This is an open, single-arm, single-dose, dose-escalation clinical trial designed to evaluate the safety and the preliminary efficacy of CB IL-10/IL-15 CD19-CAR NK cells. 6-24 patients are planned to be enrolled in the dose-escalation trial (2×10\^6 cells/kg,4×10\^6 cells/kg, 8×10\^6 cells/kg). Based on the results in the dose-escalation trial, the recommended dose will be determined. Another 30 patients will be enrolled in the dose-expansion trial. The primary endpoints are DLT and MTD; the second is the overall response rates (CR and PR), survival, and progression-free survival. Patients will be infused on day 0, day 3, and day 6, respectively.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Lentiviral vector-transducted cord blood-derived NK cells to express anti-CD19-IL10/IL-15 CAR
the Second Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGIncidence of dose limiting toxicity (DLTs)
To evaluate the safety, and tolerability, and determine the recommended dosage of cord blood-derived Anti-CD19 IL10/IL15-CAR-NK Cell Therapy for B-cell Non-Hodgkin Lymphoma
Time frame: Up to 28 days
Complete response rate (CR)
To determine the anti-tumor effectivity of CB IL-10-CD19-CAR NK
Time frame: Up to 2 years
Progression free survival (PFS)
Time frame: Up to 2 years
Duration of response (DOR)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
Partial response rate (PR)
Time frame: Up to 2 years
Overall response rate (ORR)
Time frame: Up to 2 years
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