NCT04264039: Anti-CD19 U-CAR-T Cell Therapy for B Cell Hematologic Malignancies

Study Summary

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.

Interventions

anti-CD19 UCAR-T cellsBIOLOGICAL

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

FludarabineDRUG

30mg/m\^2 per day for 6 days

CytoxanDRUG

300mg/m\^2 per day for 2 to 6 days determined by tumor burden at baseline

MelphalanDRUG

50 to 70 mg/m\^2 in total for 1 or 2 days, whether to use determined by tumor burden at baseline

Study Locations

Facility	City	State	Country
Department of Hematology, Xinqiao Hospital	Chongqing	Chongqing Municipality	China

Official Trial Information

View on ClinicalTrials.gov

Anti-CD19 Universal CAR-T Cells for CD19+ B Cell Hematologic Malignancies: a Multi-center, Uncontrolled Trial

Study Summary

Interventions

Study Locations

Official Trial Information