NCT02846584

a Clinical Research of Sequential CAR-T Bridging HSCT in the Treatment of Relapse/Refractory B-cell Malignancies

a Clinical Research of Sequential CAR-T Bridging Hematopoietic Stem Cell Transplantation in the Treatment of Relapse/Refractory B-cell Malignancies

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Southwest Hospital, China · Academic / Other
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this study is to explore the sequential therapeutic effect and evaluate the safety of anti-CD19 or anti-CD20 CAR-T cells briging HSCT in the treatment of relapse/refractory B cell malignancies.

Detailed description

The CD19-targeted CAR-T has shown exellent therapeutic efficiency in B cell malignancies,especially in acute lymphocytic leukemia. Recently the anti-CD20 CAR T cells has been used in the treatment of relapsed/refractory DLBCL and exhibited good clinical outcomes. However, patients treated with CAR-T may face relapse of CD19 or CD20 mutation. Therefore we attempt to maintain and relieve patients by sequential therapy of the HSCT and hope to combine their advantages.

Conditions

• Lymphoma, Large B-Cell, Diffuse
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma，Malignant

Interventions

Type	Name	Description
BIOLOGICAL	CD19 or CD20 CAR T cells briging HSCT	Patients will receive a one-week regimen of chemotherapy consisting of fluid arabise and cyclophosphamide aimed to deplete the lymphocytes. One week later, patients are intravenously infused autologous anti-CD19 or anti-CD20 CAR T cells.

Timeline

• Start date: 2016-07-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2016-07-27
• Last updated: 2016-09-07

Locations

1 site across 1 country: China