Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
The First Affiliated Hospital of Soochow University
To evaluate 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 in this prospective, single arm study.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | CD19CD22 CAR-T Therapy in Patients With High-Risk B Acute Lymphoblastic Leukemia (B-ALL).
