NCT03798509

Human CD19 Targeted T Cells Injection Therapy for Relapsed and Refractory CD19-positive Leukemia

A Phase I Clinical Trial to Evaluate the Safety and Tolerability of Human CD19 Targeted T Cells Injection for Subjects With Relapsed and Refractory CD19-positive B-cell Acute Lymphoblastic Leukemia

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Hrain Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerance of human CD19 targeted T Cells injection for the treatment of relapsed and refractory CD19-positive B-cell acute lymphoblastic leukemia. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.

Detailed description

Participants with relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, electrocardiograph and blood draws. Participants receive chemotherapy prior to the infusion of CD19 CAR+ T cells. After the infusion, participants will be followed for side effects and effect of CD19 CAR+ T cells. Study procedures may be performed while hospitalized.

Conditions

• CD19-positive
• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Human CD19 targeted T Cells Injection	Autologous genetically modified anti-CD19 CAR transduced T cells

Timeline

• Start date: 2019-03-13
• Primary completion: 2022-01-01
• Completion: 2024-01-01
• First posted: 2019-01-10
• Last updated: 2021-08-31

Locations

1 site across 1 country: China