A Phase 1/2 interventional study of CAR-T cell immunotherapy in B-cell Acute Lymphoblastic Leukemia, Lymphoma and Myeloid Leukemia, sponsored by Shenzhen BinDeBio Ltd.. Status unknown at 1 site in China. Open to participants aged 4 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-12-11.
Sponsored by Shenzhen BinDeBio Ltd. · Phase 1/2, Interventional, and Treatment
This is a single arm, open-label, uni-center, phase I-II study to evaluate the safety and effectiveness of CAR-T/TCR-T cell immunotherapy in treating with different malignancies patients.
The study is a multi-target gene-modified immunotherapy. CAR-T/TCR-T cells include ten different tumor-specific antibody.They are as following:anti-CD19 antibody for B cell leukemia and lymphoma;anti-CD22 antibody for B cell leukemia and lymphoma;anti-CD33 antibody for myeloid leukemia;anti-BCMA antibody for multiple myeloma;anti-CD38 antibody for multiple myeloma;anti-NY-ESO-1 antibody for multiple myeloma,esophagus cancer,lung cancer,melanoma and synovial sarcoma;anti-DR5 antibody for hepatoma;anti-C-met antibody for hepatoma,colorectal cancer,ovarian cancer and renal carcinoma;anti-EGFR V III antibody for hepatoma,lung cancer and glioma;anti-Mesothelin antibody for gastric cancer,pancreatic cancer and mesothelioma.
Exclusion Criteria:
Enrolled patients will receive CAR-T cell immunotherapy with several different specific Chimeric antigen receptors aiming at different antigens respectively by infusion.
Biological: CAR-T cell immunotherapy
According to tumor burden and other conditions, patients will be treated with cyclophosphamide or fludarabine,then,CAR-T cells will be infused 48-72 hours later.
Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0
Safety evaluation
Time frame: 60 months
Clinical response
Clinical response to T-cell infusion, especially change of tumor volume will be evaluated by comparing disease identified by computed tomography, magnetic resonance imaging.
Time frame: 60 months
CAR-T cells testing
The level of CAR-T cells will be tested regularly by Real-time Quantitative Polymerase Chain Reaction Detecting System(qPCR) or Flow cytometry to evaluate the proliferation in vivo and long-term survival.
Time frame: 60 months
Plan to share: No
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This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Shenzhen BinDeBio Ltd.