NCT04264039

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

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Xinqiao Hospital of Chongqing · Academic / Other
• Sex: All
• Age: 2 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• B-cell Acute Lymphoblastic Leukemia
• B-cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	anti-CD19 UCAR-T cells	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
DRUG	Fludarabine	30mg/m\^2 per day for 6 days
DRUG	Cytoxan	300mg/m\^2 per day for 2 to 6 days determined by tumor burden at baseline
DRUG	Melphalan	50 to 70 mg/m\^2 in total for 1 or 2 days, whether to use determined by tumor burden at baseline

Timeline

• Start date: 2020-04-01
• Primary completion: 2021-04-01
• Completion: 2022-04-01
• First posted: 2020-02-11
• Last updated: 2020-02-11

Locations

1 site across 1 country: China