Sequential Infusion of Anti-CD19 and Anti-CD20 CAR-T Cells Against Relapsed and Refractory B-cell Lymphoma
NCT03207178 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2017-07-02
Summary
Cluster of differentiation antigen 19(CD19) specifically presents in B lymphocyte cell lines steadily,while not in most normal tissue,including pluripotent hematopoietic stem cells.Cluster of differentiation antigen 20(CD20) presents in 90% of B-cell lymphomas.CD19 antigen is a well-established target for B-cell lymphomas treatment as well as CD20 antigen.Both CD19-targeting CAR T Cells and CD20-targeting CAR T Cells can be used as adoptive cellular immunotherapies for B-cell lymphomas.Though two kinds of single target treatments were proved can induce recession of B-cell lymphomas, the risk of cancer cells to escape and tumor recurrence are still existed. There are no report about combination transfer of two kinds of single target treatments.This research aimed emphasis on safety and therapeutic efficacy evaluation,as well as if combination transfer can decrease recurrence rate.
Conditions
- Recurrent or Refractory B Cell Malignancy
Interventions
- BIOLOGICAL
-
Mixed CD19/CD20 CAR-T Transfer
Autologous CD19 CAR-T cells and CD20 CAR-T cells with average 1-5\*10\^6 cells/kg body weight,separately.
Sponsors & Collaborators
-
Xuzhou Medical University
collaborator OTHER -
Shanghai Jiao Tong University School of Medicine
collaborator OTHER -
Shanghai Longyao Biotechnology Inc., Ltd.
lead OTHER
Principal Investigators
-
Shengqin Ye, M.D. · Shanghai Longyao Biotechnology Inc., Ltd.
Study Design
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-03-01
- Primary Completion
- 2019-02-28
- Completion
- 2020-02-28
Countries
- China
Study Locations
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