Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph+ B-ALL
B-Cell Acute Lymphoblastic Leukemia, Adult
About this trial
This is an interventional treatment trial for B-Cell Acute Lymphoblastic Leukemia, Adult focused on measuring CD19 CAR-T, CD22 CAR-T, Ph Chromosome Positive, B-ALL, Newly diagnosed
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Sites / Locations
- The First Affiliated Hospital, College of Medicine, Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Experimental
CAR-T therapy
Administration of CD19 and CD22 CAR T-cells