Efficacy of CART-19 Cell Therapy in B Cell Acute Lymphoblastic Leukemia
NCT02810223 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2016-10-14
Summary
This is a single arm, open-label, multi-center study to determine the efficacy and safety of an experimental therapy called CART-19 in patients with chemo-refractory and relapsed B-cell ALL.
Conditions
Interventions
- BIOLOGICAL
-
CART-19
2 to 5 x 10(6) autologous CART-19 transduced cells per kg body weight, with a maximum dose of 2.5 x 10(8) autologous CTL019 transduced cells via intravenous infusion.
Sponsors & Collaborators
-
Beijing Sanwater Biological Technology Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Year
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-05-31
- Primary Completion
- 2017-12-31
Countries
- China
Study Locations
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