Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph+ B-ALL

Prior treatment

• Women who are pregnant or breastfeeding (the safety of this therapy for the unborn child is not known);
• Those who have previously used any gene therapy product;

Other illness

• Those with a history of epilepsy or other central nervous system disorders;
• Those with uncontrolled active infection;
• Active hepatitis B or hepatitis C virus infection;
• Those who suffer from other uncontrolled medical conditions that, in the opinion of the investigator, make them unsuitable for enrollment;
• HIV-infected persons;
• Any condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the results of the test.

Lab values

• Those with a history of prolonged QT period or severe cardiac disease;
• Creatinine \> 2.5 mg/dl or ALT / AST \> 3 times the upper limit of the normal range or bilirubin \> 2.0 mg/dl;

Other

• Subjects with any of the following exclusion criteria were not eligible for enrollment in this trial:
• Those with insufficient amplification (\<5-fold) in response to CD3/CD28 co-stimulatory signals;

• Age ≥ 18 years old;
• Subjects with a diagnosis of B-cell acute lymphoblastic leukemia according to the 2016 edition of the WHO classification criteria for acute leukemia;
• Subjects whose chromosomal and fusion gene analysis showed positivity for the Ph chromosome, BCR/ABL1 fusion gene;
• Leukemia cells were CD19 and CD22 positive;
• Patients with newly diagnosed B-ALL were not treated with standard chemotherapy regimens;
• Serum total bilirubin ≤ 51 mol/L, serum ALT and AST both ≤ 3 times the upper limit of the normal range, blood creatinine ≤ 176.8 mol/L;
• Echocardiography showed a left ventricular ejection fraction (LVEF) ≥50%;
• Subjects had no active pulmonary infection and oxygen saturation ≥92% without oxygen;
• The prognosis for survival is more than 3 months;
• ECOG score 0-2;
• Subjects volunteered to participate in this trial and signed an informed consent form.