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

High Risk B-ALL

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

2024-04-20

2024-09-10

2025-09-10

Recruiting

Early phase I

20

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.

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2024-04-22