NCT05673447

The Study of Anti-CD19 CAR NK Cells in the Treatment of Relapsed/Refractory Diffuse Large B Cell Lymphoma

An Exploratory Clinical Study of Safety and Efficacy of Anti-CD19 CAR NK Cells in the Treatment of Relapsed/Refractory Diffuse Large B Cell Lymphoma

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	anti-CD19 CAR NK cells	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.

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-12-30
• Completion: 2024-12-30
• First posted: 2023-01-06
• Last updated: 2023-08-28

Locations

1 site across 1 country: China