NCT03919240

CAR-T Cell Therapy Targeting to CD19 for R/R ALL

CD19-targeting Chimeric Antigen Receptor T-cell Therapy for Patients with Refractory and Relapsed B-cell Acute Lymphoblastic Leukemia

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Refractory and relapsed (R/R) acute lymphoblastic leukemia (ALL) patients with active disease always have a dismal outcome. Chimeric antigen receptor (CAR) T-cell therapy targeting to Cluster of Differentiation Antigen 19 (CD19) has been proved as a potent approach to attain remission in B-cell R/R patients. Therefore, the investigators conduct atrial to evaluate the the efficacy and safety of locally producing CAR T cells targeting CD19, and to analyze the outcome of enrolled B-cell ALL patients with active disease or persistent residual disease.

Conditions

• Acute Lymphoblastic Leukemia with Failed Remission

Interventions

Type	Name	Description
BIOLOGICAL	CAR T-cell therapy	Patients enrolled will receive infusion of CD19-targeting CAR T-cells with a target dose of 5\~10×10E6/kg of recipient weight, after the preparative regimen consisted of fludarabin (30mg/m2, day -5 to -3) and cyclophosphamide (300mg/m2, day -5 to -3).

Timeline

• Start date: 2015-12-01
• Primary completion: 2024-08-30
• Completion: 2025-12-31
• First posted: 2019-04-18
• Last updated: 2024-10-24

Locations

1 site across 1 country: China