NCT06381830

Clinical Study of CAR-T Cell Therapy Following ASCT for R/R B-cell Non-Hodgkin's Lymphoma

Clinical Study of the Efficacy and Safety of Chimeric Antigen Receptor T-cell Therapy Following Autologous Stem Cell Transplantation for Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study is designed to evaluate the efficacy and safety of chimeric antigen receptor T-cell therapy following autologous stem cell transplantation for relapsed/refractory B-cell Non-Hodgkin's lymphoma.

Detailed description

Chimeric antigen receptor T (CAR-T) cell therapy has emerged as a promising approach for relapsed or refractory B-cell Non-Hodgkin's lymphoma (R/R B-NHL), with a complete response (CR) rate of about 50%. It is also considered to be a reasonable consolidation option in low or unmeasurable disease states recently. Unfortunately, 40%-70% of patients experienced relapse after CAR-T cell therapy in the long-term follow up. Autologous stem cell transplantation (ASCT) with myeloablative chemotherapy can enhance the efficiency of CAR-T cells and alleviate tumor load, leading to a lower relapse rate. As a result, CAR-T cell therapy following ASCT may be a promising method for R/R LBCL patients.

Conditions

• Lymphoma, B-Cell
• Autologous Stem Cell Transplantation

Interventions

Type	Name	Description
OTHER	Apheresis	Participants will undergo two separate apheresis procedures, including: G-CSF primed hematopoietic stem cell collection and peripheral blood mononuclear cell apheresis for CAR-T cell manufacturing.
OTHER	Autologous Stem Cell Transplantation	Participants are designed to receive myeloablative conditioning regimen prior to infusion of a minimum 2 x 10\^6 CD34+ stem cells/kilogram.
DRUG	CAR-T Cell Therapy	CAR-T cells will be infused within 7 days after autologous hematopoietic stem cell infusion (2-10×10\^6 CAR-T/kg，ivgtt).

Timeline

• Start date: 2024-01-01
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2024-04-24
• Last updated: 2024-04-24

Locations

1 site across 1 country: China