The stunning response rate of anti-CD19(cluster of differentiation antigen 19) auto-CAR(chimeric antigen receptor)-T cell therapy brings hope to patients with relapsed or refractory B-cell hematologic malignancies. However, based on open clinical trials, using patients' T cells might encounter the failure of apheresis available T cells, even if successful, the time needed for the manufacture could also cause the irreversible disease progress. Furthermore, the cost of auto-CAR-T cells is not affordable for most patients. So to provide an accessible and affordable anti-CD19 CAR-T cell therapy for patients with B-cell hematologic malignancies, we launch such a trial that using the edited T cells from healthy donors to manufacture universal CAR-T cells and adapt it in patients with CD19+ B-cell leukemia or lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Dose range:1 to 5 ×10\^7 cells/Kg, Dose level one: 1×10\^7 cells/Kg, Dose level two: 3×10\^7 cells/Kg, Dose level three:5 ×10\^7 cells/Kg
30mg/m\^2 per day for 6 days
300mg/m\^2 per day for 2 to 6 days determined by tumor burden at baseline
50 to 70 mg/m\^2 in total for 1 or 2 days, whether to use determined by tumor burden at baseline
Department of Hematology, Xinqiao Hospital
Chongqing, Chongqing Municipality, China
the anti-tumor efficiency of anti-CD19 UCAR-T cells
ratio of bone marrow blast cells and/or the measurable lesion size and strandralized uptake value
Time frame: 4 weeks after infusion
the long-term efficiency of anti-CD19 UCAR-T cells
ratio of bone marrow blast cells and/or the measurable lesion size and strandralized uptake value
Time frame: 3 and 6 months after infusion
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