NCT05667155

Clinical Study of Cord Blood-derived CAR NK Cells Targeting CD19/CD70 in Refractory/Relapsed B-cell Non-Hodgkin Lymphoma

• Status: Unknown
• 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 efficacy of cord blood-derived CAR-NK cells targeting CD19/CD70 in patients with B-cell non-Hodgkin's lymphoma

Detailed description

This is a single-center, open, one-arm, dose-escalation study to observe the safety and efficacy of cord blood-derived dualCAR-NK19/70 cells in patients with B-cell non-Hodgkin lymphoma.9-18 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) . Each dose was given once a week for 3 weeks.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	CB dualCAR-NK19/70	Lentiviral vector-transducted cord blood-derived NK cells to express anti-CD19/CD70 CAR and IL15

Timeline

• Start date: 2022-12-15
• Primary completion: 2025-01-01
• Completion: 2025-12-30
• First posted: 2022-12-28
• Last updated: 2023-02-06

Locations

1 site across 1 country: China