NCT04626739

CAR-T Cells in Treating Patients With Relapsed or Refractory NHL

An Open, Uncontrolled, Multicenter Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of Chimeric Antigen Receptor T Cell (CAR-T) in the Treatment of Relapsed Refractory (R/R) Non-Hodgkin Lymphoma (NHL)

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hebei Senlang Biotechnology Inc., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open, single-arm, phase I clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Non-hodgkin's lymphoma. A total of 100 patients are planned to be enrolled over a period of 3 years.

Detailed description

Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. In this study, investigators will evaluate their safety and efficacy in patients with different types of hematopoietic and lymphoid malignancies. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.

Conditions

• Refractory Indolent Adult Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	CD19 CAR-T	CD19 CAR-T for CD19 positive R/R non-Hodgkin lymphoma
DRUG	CD22 CAR-T	CD22 CAR-T for CD22 positive R/R non-Hodgkin lymphoma
DRUG	CD19+CD22 CAR-T	CD19+CD22 CAR-T for CD19 positive and CD22 positive R/R non-Hodgkin lymphoma
DRUG	Fludarabine	25mg/㎡ for D-4、D-3 and D-2
DRUG	Cyclophosphamide	500mg/㎡ for D-3 and D-2

Timeline

• Start date: 2020-04-01
• Primary completion: 2023-03-30
• Completion: 2023-03-30
• First posted: 2020-11-13
• Last updated: 2020-11-13

Locations

1 site across 1 country: China