NCT03344705

Safety and Efficacy Evaluation of IM19 Cells

Safety and Efficacy Evaluation of IM19 Chimeric Antigen Receptor-modified T Cells (IM19CAR-T) In CD19+ B Cell Malignancies

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd. · Industry
• Sex: All
• Age: 4 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Assessment of the Safety and Feasibility of Administering T cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell Hematological Malignancies.

Detailed description

Assessment of the Safety and Feasibility of Administering T cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell Hematological Malignancies(including B-cell Acute lymphoblastic Leukemia、B-cell Chronic Lymphocytic Leukemia、Non-Hodgkin's lymphoma) and Determine the Best Dosage.

Conditions

• Hematological Malignancies

Interventions

Type	Name	Description
BIOLOGICAL	IM19 CAR-T	All patients will be treated with fludarabine and cyclophosphamide for 3 days. Two days later, Cells Expressing an Anti-CD19 Chimeric Antigen Receptor will be infused.
DRUG	Fludarabine	Two days before cell infusion,all patients will be treated with fludarabine for 3 days
DRUG	Cyclophosphamide	Two days before cell infusion,all patients will be treated with cyclophosphamide for 3 days

Timeline

• Start date: 2017-08-21
• Primary completion: 2020-10-01
• Completion: 2020-12-01
• First posted: 2017-11-17
• Last updated: 2017-11-17

Locations

1 site across 1 country: China