Последовательная терапия CAR-T-клетками CD5/CD7-положительных Т-клеток, острого лимфобластного лейкоза и лимфобластной лимфомы с использованием CD5/CD7-специфичных CAR-T-клеток (BAH246)

Inclusion Criteria:

• Signed written informed consent; Patients volunteer to participate in the clinical trial;
• Diagnosis is mainly based on the World Health Organization (WHO) 2008;
• Complete remission cannot be achieved after induction therapy; recurrence occurs after completion remission; the burden of leukemic blasts in the peripheral blood or bone marrow is greater than 5%;
• Leukemic blast cells express CD7/CD5 (CD7 OR CD5 positive by flow cytometry or immunohistochemistry ≥70%);
• The expected survival period is greater than 12 weeks;
• ECOG score ≤2;
• Age 2-60 years old;
• HGB≥70g/L (can be transfused);
• Total bilirubin does not exceed 3 times the upper limit of normal value, and AST and ALT do not exceed 5 times the upper limit of normal value.

Exclusion Criteria:

• Patients declining to consent for treatment
• Prior solid organ transplantation
• One of the following cardiac issues: atrial fibrillation; myocardial infarction within the past 12 months; prolonged QT syndrome or secondary QT prolongation; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV;
• History of severe pulmonary dysfunction diseases;
• Severe infection or persistent infection cannot be effectively controlled;
• Severe autoimmune disease or congenital immunodeficiency;
• Active hepatitis;
• Human immunodeficiency virus (HIV) infection;
• Clinically significant viral infections, or uncontrollable viral reactivation, including EBV (Epstein-Barr virus).