A Phase 2 interventional study of CD19 or CD20 CAR T cells briging HSCT in Lymphoma, Large B-Cell, Diffuse, Leukemia, Lymphocytic, Chronic, B-Cell and Lymphoma,Malignant, sponsored by Southwest Hospital, China. Status unknown at 1 site in China. Open to participants aged 14 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-07.
Sponsored by Southwest Hospital, China · Phase 2, Interventional, and Treatment
The main purpose of this study is to explore the sequential therapeutic effect and evaluate the safety of anti-CD19 or anti-CD20 CAR-T cells briging HSCT in the treatment of relapse/refractory B cell malignancies.
The CD19-targeted CAR-T has shown exellent therapeutic efficiency in B cell malignancies,especially in acute lymphocytic leukemia. Recently the anti-CD20 CAR T cells has been used in the treatment of relapsed/refractory DLBCL and exhibited good clinical outcomes.
However, patients treated with CAR-T may face relapse of CD19 or CD20 mutation. Therefore we attempt to maintain and relieve patients by sequential therapy of the HSCT and hope to combine their advantages.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Southwest Hospital, China is the lead sponsor of 85 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
lentiviral transfection and transfuse anti-CD19 or anti-CD20 CAR T cells into patients. Six months later, select appropriate patients to transplant hemopoietic stem cells.
Biological: CD19 or CD20 CAR T cells briging HSCT
Patients will receive a one-week regimen of chemotherapy consisting of fluid arabise and cyclophosphamide aimed to deplete the lymphocytes. One week later, patients are intravenously infused autologous anti-CD19 or anti-CD20 CAR T cells.
Overall survival rate of patients treated with anti-CD19 or anti-CD20 CAR T cells
Time frame: 2 years
Treatment response rate of anti-CD19 CAR T cell infusion
Time frame: 4 weeks
Number of patients with adverse events
Time frame: 2 years
Plan to share: No
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This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Southwest Hospital, China