NCT03671460

CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.

Phase I Study of the Safety and Efficacy of CD19 CAR-T Cells in Patients With Relapsed or Refractory Acute B-cell Lymphoblastic Leukemia (R/R B-ALL)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Tianjin Mycure Medical Technology Co., Ltd · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).

Detailed description

In this single-center, open-label, nonrandomized, no control, prospective clinical trial, no less than 18 CD19+ B-cell relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL) patients will be enrolled. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with R/R B-ALL.

Conditions

• B-cell Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	CD19 CAR-T cells	T cells purified from the PBMC of subjects, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.

Timeline

• Start date: 2018-09-07
• Primary completion: 2020-01-01
• Completion: 2021-01-01
• First posted: 2018-09-14
• Last updated: 2018-09-14

Locations

1 site across 1 country: China