A Phase 1/2 interventional study of anti-CD19 CAR-T and Fludarabine in Hematopoietic/Lymphoid Cancer, Adult Acute Lymphoblastic Leukemia in Remission and B-cell Adult Acute Lymphoblastic Leukemia, sponsored by The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine. Status unknown at 1 site in China. Open to participants aged 5 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-03-16.
Sponsored by The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine · Phase 1/2, Interventional, and Treatment
This is a single-arm open-label phase I/II study to determine the relative superiority of αCD19-TCRζ-CD28 and αCD19-TCRζ-CD137 CAR-T Cells in safety, efficacy and engraftment potential in patients with CD19+ B-lineage leukemia and lymphoma. Recently, cancer immunotherapy, treatments aiming to arm patients with immunity specifically against cancer cells, has emerged as a promising therapeutic strategy. Clinical trials utilizing CARs against B cell malignancies have demonstrated remarkable potential. In this trial, all subjects will be competitively infused with αCD19-TCRz-CD28 and αCD19-TCRz-CD137 CAR-T cells in equal number to test a hypothesis that CD137-costimulation can promote the persistence and engraftment of CAR-T cells and this superiority can lead to improved progression-free survival.
Primary objectives
Secondary objectives
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Histologically confirmed as CD19-positive lymphoma/leukemia and who meet one of the following conditions;
Exclusion Criteria:
All subjects will be infused with αCD19-TCRz-CD28 and αCD19-TCRz-CD137 CAR-T cells in equal number
Biological: anti-CD19 CAR-T · Drug: Fludarabine · Drug: Cyclophosphamide
Ex vivo-expanded autologous T cells modified to express CD19 CAR
Safety (incidence of adverse events defined as dose-limited toxicity)
Time frame: 30 days
Overall complete remission rate
Time frame: 8 weeks
Survival of CAR T cells in circulation measured by flow cytometry and PCR
Time frame: 1 year
Duration of remission
Time frame: 1 year
Overall survival
Time frame: 1 year
Plan to share: Undecided
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This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine