Recurrent or Refractory B Cell Malignancy Clinical Trial
Official title:
Sequential Infusion of Anti-CD19 and Anti-CD20 Chimeric Antigen Receptor(CAR) T Cells Against Relapsed and Refractory B-cell Lymphoma
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.
To determine:
Primary Outcome Measure:
The Overall complete remission rate and one-year survival rate of combination transfer of
CD19-targeting CAR T Cells and CD20-targeting CAR T Cells is superior to or at least not
worse than two kinds of single target treatments in the treatment of CD19+/CD20+ B-cell
lymphomas.
The risk of cancer recurrence in a year of combination transfer of CD19-targeting CAR T Cells
and CD20-targeting CAR T Cells is inferior to two kinds of single target treatments.
Secondary Outcome Measures:
Evaluate the initial effect time, time to disease progression, and life quality improvement
of combination transfer compare to single target treatments.
Evaluate the safety and tolerability of combination transfer compare to single target
treatments by observation of high fever duration in patients and testing related cell factor
level in peripheral blood.
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Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02794961 -
CD22 Targeting CAR-T Therapy Against B Cell Hematological Malignancies
|
Phase 1/Phase 2 |