This is a prospective, single arm study. To evaluate the safety and efficacy of sequential CD19 and CD22 CAR-T cells in the treatment of adult newly diagnosed Ph chromosome negative B-cell acute lymphoblastic leukemia. The main endpoints were dose limiting toxicity (DLT) and incidence of adverse events (TEAEs).
Age
15–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age≥15 years old
Newly diagnosed B-cell acute lymphoblastic leukemia according to the 2016 WHO classification
The immunophenotype of leukemia cells were CD19 and CD22 positive
Ph- or Ph- like negative
Anticipated survival time more than 12 weeks;
Those who voluntarily participated in this trial and provided informed consent.
You may not be if
History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
Pregnant (or lactating) women;
Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
Active infection of hepatitis B virus or hepatitis C virus;
Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids;
Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
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;
Patients with HIV infection;
Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Clareo Health | Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph- B-ALL
