Evaluation of the Safety and Efficacy of Sup19 CAR-T Cells in Patients With Previously Failed CD19-Targeted Therapy or CD19-Weakly Expressed Hematologic Tumors

Exclusion Criteria

• •Acute promyelocytic leukemia (APL);
• •presence of hereditary syndromes such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known myelodysplastic syndrome;
• •uncontrolled active central nervous system leukemia (CNSL), i.e., cerebrospinal fluid (CSF) classification CNS 3;
• •Had uncontrolled severe active infection at screening;
• •Had a history of severe heart disease, including: severe heart dysfunction (according to the New York Heart Association (NYHA) cardiac function classification criteria, subjects with grade III or V cardiac dysfunction), myocardial infarction within 12 months or undergoing coronary angioplasty or stent placement, unstable angina pectoris, or electrocardiogram indicating a significantly prolonged QT interval (\>480ms) or the investigator determined severe arrhythmia;
• •Had a history of head trauma, consciousness disorder, epilepsy, cerebrovascular ischemia, or cerebrovascular hemorrhagic disease, and required medication within the past 6 months;
• •Had hepatitis B surface antigen (HBsAg) greater than 10E6 IU/mL at screening; positive hepatitis C virus (HCV) antibody; positive human immunodeficiency virus (HIV) antibody; positive syphilis antibody; EBER positive or EBV copy number \> upper limit of normal;
• •Those who require the use of steroid hormones during CAR-T infusion (except for those using inhaled steroid hormones locally); subjects who are receiving systemic steroid treatment before screening and whose study investigators determine that they need long-term systemic steroid treatment during the treatment period (excluding those using inhaled or local steroid hormones);
• •Subjects with treatable autoimmune diseases, immunodeficiency or those requiring immunosuppressive therapy;
• •Subjects who had acute graft-versus-host disease (GvHD) or moderate to severe chronic GvHD within 4 weeks before screening;
• •Subjects with a history of allergy to any component of the cell product;
• •Pregnant or lactating women, as well as male or female subjects who have reproductive capacity and cannot take effective contraceptive measures within 1 year after cell infusion (regardless of gender); male subjects who plan to conceive within 1 year after cell infusion; female subjects or their partners who plan to conceive within 1 year after cell infusion;
• •Any situation that the investigator considers may increase the risk for the subject or interfere with the test results.