NCT05312476

Clinical Study on CAR-T Targeting Igβ Targets in Refractory Relapsed Non-Hodgkin's Lymphoma

Clinical Study of the Safety, Tolerability and Preliminary Efficacy of Chimeric Antigen Receptor T Cells (CAR-T) Targeting Igβ Targets in Patients With Igβ-positive Refractory Relapsed Non-Hodgkin's Lymphoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

Aim of this study will evaluate the safety, tolerability and preliminary efficacy of chimeric antigen receptor T cells (CAR-T) targeting Igβ targets in patients with Igβ-positive refractory relapsed non-Hodgkin's lymphoma.

Detailed description

Non-Hodgkin's lymphoma is a group of malignant neoplasms of the lymphatic system originating from B or T cells, of which 60-70% of patients have B-cell-derived lymphoma (B-NHL). Although rituximab in combination with chemotherapy has significantly improved the prognosis of B-cell lymphoma, some patients still have primary resistance or relapse. In recent years, breakthroughs have been made in the treatment of B-cell tumors with Chimeric Antigen Receptor-Modified T Cells (CART), the investigators therefore constructed CAR-T cells targeting Igβ to investigate the safety and efficacy of CAR-T cells with this target for the treatment of r/r B-NHL.

Conditions

• Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Chimeric Antigen Receptor T Cells (CAR-T) Targeting Igβ Targets	1. Dose escalation studies:3 dose groups in total: expect 3-6 cases in each group, and dose set at 1×106/kg，3×106/kg，6×106/kg. 2. Dose extension study:3 cases (1 dose group).

Timeline

• Start date: 2022-02-10
• Primary completion: 2025-02-10
• Completion: 2025-02-10
• First posted: 2022-04-05
• Last updated: 2022-04-05

Locations

1 site across 1 country: China