NCT04508842

CD19/CD22-Dual-STAR-T for Patients With B Cell Acute Leukemia(B-ALL)

The Phase I Efficacy and Safety Clinical Study of CD19/CD22-Dual-STAR-T Cells in Relapsed and Refractory B-ALL.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Hebei Yanda Ludaopei Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single center, single arm, open-lable phase I study to determine the safety and efficacy of CD19/CD22-Dual-STAR-T cells in patients with refractory and relapsed B cell acute leukemia .

Detailed description

Patients with B cell acute leukemia will be enrolled, and Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of Dual-STAR-T cells.Dual-STAR-T cells will be intravenously infused with a escalated dose of 6E5、1E6、2E6、3E6 cells/kg.The purpose of current study is to evaluate the clinical safety and efficacy of CD19/CD22-Dual-STAR-T cells therapy in patients with refractory and relapsed B-ALL.Safety and efficacy of Dual-STAR-T cells therapy will be monitored. The primary endpoint is the safety of Dual-STAR-T cells including the effect ratio of CRS and ICANS, ORR. The secondary endpoint is the Dual-STAR-T cell proliferation ratio and Dual-STAR gene copied number in peripheral blood（PB）， and progression free survival(PFS ), overall-survival(OS) and duration of overall response(DOR).

Conditions

• Refractory and Relapsed B Cell Acute Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	CD19/CD22-Dual-STAR-T	Patients with B cell acute leukemia will be enrolled, and Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of CD19/CD22-Dual-STAR-T cells.Dual-STAR-T cells will be intravenously infused with a escalated dose of 6E5、1E6、2E6、3E6 cells/kg.

Timeline

• Start date: 2020-10-10
• Primary completion: 2022-05-01
• Completion: 2022-05-01
• First posted: 2020-08-11
• Last updated: 2022-09-28

Locations

1 site across 1 country: China