Study Evaluating the Efficacy and Safety With CAR-T Immunotherapy for CD19 Positive Lymphoma
NCT03086954 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2017-03-22
Summary
This open, single-arm,multicenter 2 phase clinical study will treat the patient who have CD19 positive lymphoma with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor(CAR)that will bind to tumour cells modified to express the CD19 protein on the cell surface. The study will determine if these modified T cells help the body's immune system eliminate tumour cells .The trial will also study the safety of treatment for CAR-T, how long CAR-T cells stay in the patient's body and the impact on this treatment for survival.
Conditions
Interventions
- BIOLOGICAL
-
The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T)
This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-CD19-modified T cells can recognize and kill tumor cells in the body,follow-up 35 months.
Sponsors & Collaborators
-
Jiangsu Cancer Institute & Hospital
collaborator OTHER -
Sinobioway Cell Therapy Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jifeng Feng, Professor · Director of medical oncology
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-04-30
- Primary Completion
- 2021-03-31
- Completion
- 2021-03-31
Countries
- China
Study Locations
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