CD19CD22 CAR-T Therapy in Patients With High-Risk B Acute Lymphoblastic Leukemia (B-ALL).
NCT06078306 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2024-04-22
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
Conditions
- B Acute Lymphoblastic Leukemia
- Ph-Negative ALL
- High Risk Acute Lymphoblastic Leukemia
Interventions
- DRUG
-
Azacitidine Injection
Azacitidine Injection 75mg/square meter/day, day1-7, subcutaneous injection
- DRUG
-
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
Sponsors & Collaborators
-
The First Affiliated Hospital of Soochow University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-20
- Primary Completion
- 2024-09-10
- Completion
- 2025-09-10
Countries
- China
Study Locations
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