NCT02537977

CD19-directed CAR T Cells Therapy in Relapsed/Refractory B Cell Malignancy

CD19-directed Chimeric Antigen Receptor T Cells Therapy in Relapsed/Refractory B Cell Malignancy

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine · Academic / Other
• Sex: All
• Age: 6 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Relapsed/refractory leukemia and lymphoma lack effective treatment. The cancer immunotherapy with chimeric antigen receptor (CAR) T cells provides a potent new approach for them. In this clinical trial, the investigators aim to assess the safety and efficacy of administering T cell expressing an anti-CD19 CARs to patients with chemotherapy resistant or refractory CD19 positive B cell malignancy including leukemia and lymphoma.

Detailed description

Tongji Hospital of Tongji University has developed an investigational approach for treating patients with CD19 positive B cell malignancy that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with lentivirus to attack CD19 positive cells, and then giving the cells back to the patients.The main purpose of the study is to assess the safety and efficacy of the treatment with anti-CD19 CAR-T cells in the patients with chemotherapy resistant or refractory CD19 positive B cell malignancy including leukemia and lymphoma.

Conditions

• Leukemia
• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	CD19-directed CAR-T cells	CD19-directed CAR-T cell infusion will be given by vein

Timeline

• Start date: 2015-07-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2015-09-02
• Last updated: 2018-12-03

Locations

1 site across 1 country: China