drugset / Trial / NCT02975687

CD19 CAR T Cells in Patients With Resistant or Refractory CD19+ Acute Lymphoblastic Leukemia

NCT02975687

NaSingle-groupOpen-labelTreatment

Summary

In this single-center, open-label, no control, prospective clinical trial, a total of 20 resistant or refractory CD19+ B cell acute lymphoblastic leukemia (ALL) patients will be enrolled. CD19 CAR T cells will be administered by i.v. injection as a using a "split dose" (total dose of 5x10\^6/kg-5x10\^7/kg) approach to dosing:10% on day 0, 30% on day 1 and 60% on day 2. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells in patients with chemotherapy resistant or refractory CD19+ ALL.

Timeline

Start
2016-11
Primary completion
2018-12
Completion
2018-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject CD19 CAR-T cells Cell therapy 5e+06 cells/kg Intravenous
Subject CD19 CAR-T cells Cell therapy 5e+07 cells/kg Intravenous