Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
NCT ID:
NCT06078306
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06078306
Study Brief:
Protocol Section:
NCT06078306