NCT04740203

Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph- B-ALL

Clinical Trial for the Safety and Efficacy of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Negative B-cell Acute Lymphoblastic Leukemia

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

Clinical Trial for the Safety and Efficacy of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Negative B-cell Acute Lymphoblastic Leukemia

Detailed description

This is a prospective, single arm study. To evaluate the safety and efficacy of sequential CD19 and CD22 CAR-T cells in the treatment of adult newly diagnosed Ph chromosome negative B-cell acute lymphoblastic leukemia. The main endpoints were dose limiting toxicity (DLT) and incidence of adverse events (TEAEs).

Conditions

• B-Cell Acute Lymphoblastic Leukemia, Adult

Interventions

Type	Name	Description
DRUG	CAR-T cells targeting CD19 and CD22	Each subject receives sequential CD19 and CD22 CAR-T cells by intravenous infusion

Timeline

• Start date: 2021-01-31
• Primary completion: 2024-01-31
• Completion: 2025-01-31
• First posted: 2021-02-05
• Last updated: 2021-02-05

Locations

1 site across 1 country: China