NCT06078306

CD19CD22 CAR-T Therapy in Patients With High-Risk B Acute Lymphoblastic Leukemia (B-ALL).

Clinical Trial for the Safety and Efficacy of Induction Chemotherapy With Azacitidine+Venetoclax (VA) and Bridging CD19CD22 CAR-T Therapy in Adult Patients With Newly Diagnosed High-Risk and Ph-negative (Ph-) B-ALL

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Clinical trial for the safety and efficacy of induction chemotherapy with VA regime and bridging CD19CD22 CAR-T therapy in adult patients with newly diagnosed high-risk and Ph- B-ALL

Detailed description

To evaluate the safety and efficacy of induction chemotherapy with VA regime and bridging CD19CD22 CAR-T therapy in Adult patients with newly diagnosed high-risk and Ph- B-ALL in this prospective, single arm study.

Conditions

• B Acute Lymphoblastic Leukemia
• Ph-Negative ALL
• High Risk Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Azacitidine Injection	Azacitidine Injection 75mg/square meter/day, day1-7, subcutaneous injection
DRUG	Venetoclax	Venetoclax 100mg day 1, 200mg day 2, 400mg d3-d21, oral
DRUG	CD19CD22 CAR-T	After induction chemotherapy with Azacitidine+Venetoclax, each subject receives CD19CD22 CAR-T cells by intravenous infusion

Timeline

• Start date: 2024-04-20
• Primary completion: 2024-09-10
• Completion: 2025-09-10
• First posted: 2023-10-11
• Last updated: 2024-04-22

Locations

1 site across 1 country: China