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

• Status: Recruiting
• Trial end date: 2025-09-10
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Soochow University
• Treatments: Azacitidine; Venetoclax

Criteria

Inclusion Criteria:

1. Age≥18 and ≤65 years old

2. Newly diagnosed and high risk B-ALL according to the 2022 WHO classification

3. The immunophenotype of leukemia cells were CD19 and CD22 positive and Ph-;

4. Anticipated survival time more than 12 weeks;

5. Those who voluntarily participated in this trial and provided informed consent.

Exclusion Criteria:

1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;

2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;

3. Pregnant (or lactating) women;

4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);

5. Human immunodeficiency virus (HIV) positive; Active infection of hepatitis B virus or hepatitis C virus

6. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;

7. Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;

8. Other uncontrolled diseases that were not suitable for this trial;

9. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.