Study Evaluating the Efficacy and Safety With CAR-T for Recurrent or Refractory Diffuse Large B Cell Lymphoma
NCT02728882 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2017-03-23
Summary
This single-arm, multicenter Phase 2 study will treat the patients who have Recurrent or refractory diffuse large B cell 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 that express the EPCAM 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 with CAR-T,how long CAR-T cells stay in the patient's body and the impact of this treatment on survival.
Conditions
Interventions
- BIOLOGICAL
-
CD19-targeted CAR-T cells
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
-
The First Affiliated Hospital of Anhui Medical University
collaborator OTHER -
Sinobioway Cell Therapy Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Kangsheng Gu, PI · Chief physician
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 3 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-07-02
- Primary Completion
- 2019-07-31
- Completion
- 2019-07-31
Countries
- China
Study Locations
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