NCT05472558

Clinical Study of Cord Blood-derived CAR-NK Cells Targeting CD19 in the Treatment of Refractory/Relapsed B-cell NHL

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To study the safety and effectiveness of cord blood-derived CAR-NK cells targeting CD19 in patients with B-cell non-Hodgkin's lymphoma

Detailed description

This is an open, single-arm, single-dose, dose-escalation clinical trial designed to evaluate the safety and the preliminary efficacy of CB CAR-NK019 cells. 9-18 patients are planned to be enrolled in the dose-escalation trial (2×10\^6 cells/kg ,3×10\^6 cells/kg, 4×10\^6 cells/kg) . The primary endpoints are DLT, MTD, and the second endpionts are the overall response rates (CR and PR), overall survival, and progression-free survival. Based on the results in the dose-escalation trial, the recommended dose will be determined. Another 30 patients will be enrolled to estimate the safety and efficacy of CB CAR-NK019 under the best dose.

Conditions

• B-cell Non Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	anti-CD19 CAR-NK	lentiviral vector-transducted cord blood-derived NK cells to express anti-CD19 CAR

Timeline

• Start date: 2022-07-26
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2022-07-25
• Last updated: 2025-03-04

Locations

1 site across 1 country: China