NCT05410041

Anti-CD19 CAR-Engineered NK Cells in the Treatment of Relapsed/Refractory B-cell Malignancies

Safety and Efficacy of Anti-CD19 CAR-Engineered NK Cells for Relapsed/Refractory B-cell Malignancies: a Multi-center, Open-label, Single-arm Clinical Study

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Beijing Boren Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single arm, open and multi center exploratory clinical study to observe the safety and effectiveness of CAR NK-CD19 in participants with recurrent or refractory CD19 positive B-cell malignant tumors, and preliminarily evaluate the expansion of this product in vivo and the objective remission rate after administration.

Detailed description

The study will enroll 9-21 participants diagnosed with recurrent or refractory CD19 positive B-cell malignant tumors, including acute B-lymphocyte leukemia, B-cell non-Hodgkin's lymphoma and chronic B-lymphocyte leukemia. There will be three preset dose groups in this clinical trial, which are 1.0×10\^7、2.0×10\^7 and 3.0×10\^7 CAR positive NK cells / kg (body weight), SRC will discuss and decide the next infusion plan. Participants will be enrolled from low dose group to high dose group, each dose will enroll at least 3 cases. Dose escalation will be decided by the SRC (Safety Review Committee) separately by diseases. There will be expanded cases in the aim dose group, which will at most to 6 cases. The protocol will be performed into screening period (-30\~-10 days), prophase of lymophodepletion (-10\~-5 days), Lymophodepletion (-5\~-3 days), pre-infusion evaluation (-2\~-1 days), infusion (day 0), and follow-up period (1-720 days). According to the administration strategy, we will start from single administration. Only after the SRC's decision based on safety and PK data, we could explore further on multiple administrations or combo therapy strategy.

Conditions

• Acute Lymphocytic Leukemia
• Chronic Lymphocytic Leukemia
• Non Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	CAR-NK-CD19 Cells	CAR-NK-CD19 Cells, 1-3×10\^7 /KG, treatment follows a lymphodepletion. Drug: Fludarabine Recommendation: 25-30 mg/kg (D-5\~D-3), determined by tumor burden at baseline. Drug: Cyclophosphamide Recommendation: 250-300 mg/kg (D-5\~D-3), determined by tumor burden at baseline.

Timeline

• Start date: 2022-05-25
• Primary completion: 2023-04-01
• Completion: 2024-05-01
• First posted: 2022-06-08
• Last updated: 2022-06-08

Locations

1 site across 1 country: China