Last updated: April 19, 2024
Sponsor: The First Affiliated Hospital of Soochow University
Overall Status: Active - Recruiting
Phase
2
Condition
Leukemia
Treatment
Venetoclax
Azacitidine Injection
CD19CD22 CAR-T
Clinical Study ID
NCT06078306
High Risk B-ALL
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age≥18 and ≤65 years old
- Newly diagnosed and high risk B-ALL according to the 2022 WHO classification
- The immunophenotype of leukemia cells were CD19 and CD22 positive and Ph-;
- Anticipated survival time more than 12 weeks;
- Those who voluntarily participated in this trial and provided informed consent.
Exclusion
Exclusion Criteria:
- History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascularischemia, and cerebrovascular hemorrhagic diseases;
- Electrocardiogram shows prolonged QT interval, severe heart diseases such as severearrhythmia in the past;
- Pregnant (or lactating) women;
- Patients with severe active infections (excluding simple urinary tract infection andbacterial pharyngitis);
- Human immunodeficiency virus (HIV) positive; Active infection of hepatitis B virus orhepatitis C virus
- Previously treated with any CAR-T cell product or other genetically-modified T celltherapies;
- Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;
- Other uncontrolled diseases that were not suitable for this trial;
- Any situations that the investigator believes may increase the risk of patients orinterfere with the results of study.
Study Design
Total Participants: 20
Treatment Group(s): 3
Primary Treatment: Venetoclax
Phase: 2
Study Start date:
April 20, 2024
Estimated Completion Date:
September 10, 2025
Study Description
Connect with a study center
Xiaowen Tang
Suzhou, Jiangsu 215000
ChinaActive - Recruiting

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