NCT04814004

Clinical Study of CAR-iNKT Cells in the Treatment of Relapsed/Refractory/High-risk B-cell Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Kai Lin Xu; Jun Nian Zheng · Academic / Other
• Sex: All
• Age: 5 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety and feasibility of hCD19.IL15.CAR-iNKT cells in treating patients with relapsed/refractory/high-risk B-cell tumors.

Detailed description

CD19 CAR-T has been shown to treat a variety of refractory or recurrent B-cell tumors. Because most CAR-T cells are generated from the patient's own T cells and are individualized products, and there are individual differences between patients, the generation of customized CAR-T cells is an expensive and time-consuming process. Universal CAR- iNKT cells are an ideal product for cell therapy. In this study, we prepared universal iNKT cells expressing hCD19 CAR and IL-15 to treat refractory, relapsed, or high-risk B-cell tumors.

Conditions

• Acute Lymphoblastic Leukemia
• B-cell Lymphoma
• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	hCD19.IL15.CAR-iNKT	Universal hCD19.IL15.CAR-iNKT cells by a single infusion intravenously will be given in escalating doses.

Timeline

• Start date: 2021-03-19
• Primary completion: 2023-04-01
• Completion: 2024-04-01
• First posted: 2021-03-24
• Last updated: 2021-03-29

Locations

1 site across 1 country: China