drugset / Trial / NCT02975687
CD19 CAR T Cells in Patients With Resistant or Refractory CD19+ Acute Lymphoblastic Leukemia
Phase 1
Completed
20 enrolled
Institute of Hematology & Blood Diseases Hospital, China
Juventas Cell Therapy Ltd. · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD19 CAR-T cells | Cell therapy | 5e+06 cells/kg | Intravenous |
| Subject | CD19 CAR-T cells | Cell therapy | 5e+07 cells/kg | Intravenous |