Clinical Research Directory

Inclusion Criteria Subjects must meet all of the following criteria to be enrolled: 1. • Aged 18 to 75 years, male or female; 2. • Histologically or cytologically diagnosed with relapsed/refractory CD19-positive hematologic malignancy according to the 2022 World Health Organization (WHO) diagnostic criteria; 3. • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 4. • Life expectancy of at least 3 months; 5. • No contraindications to peripheral blood leukapheresis; 6. • CD19 expression on tumor cells confirmed by flow cytometry and/or immunohistochemistry; 7. • No severe cardiac, pulmonary, hepatic, or renal dysfunction; 8. • Able to understand and willing to provide written informed consent. Exclusion Criteria Subjects who meet any of the following criteria should be excluded from enrollment: 1. History of allergy to any component of the cellular product; 2. Complete blood count meeting any of the following criteria: white blood cell count (WBC) ≤1 × 10⁹/L, absolute neutrophil count (ANC) ≤0.5 × 10⁹/L, absolute lymphocyte count (ALC) ≤0.5 × 10⁹/L, or platelet count (PLT) ≤25 × 10⁹/L; 3. Laboratory abnormalities including, but not limited to, serum total bilirubin ≥1.5 mg/dL; serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 times the upper limit of normal; or serum creatinine ≥2.0 mg/dL; 4. Class III or IV cardiac insufficiency according to the New York Heart Association (NYHA) functional classification, or left ventricular ejection fraction (LVEF) \<50% by echocardiography; 5. Abnormal pulmonary function, with oxygen saturation \<92% on room air; 6. History of myocardial infarction, cardiac angioplasty or stent placement, unstable angina, or other clinically significant severe cardiac disease within 12 months prior to enrollment; 7. Grade 3 hypertension with poor blood pressure control despite medication; 8. History of traumatic brain injury, disturbance of consciousness, epilepsy, severe cerebral ischemia, or cerebral hemorrhagic disease; 9. Autoimmune disease, immunodeficiency, or other conditions requiring treatment with immunosuppressive agents; 10. Uncontrolled active infection; 11. Prior treatment with any CAR-T cell product or other genetically modified T-cell therapy; 12. Receipt of a live vaccine within 4 weeks prior to enrollment; 13. Positive test results for HIV, HBV, HCV, or TPPA/RPR, or HBV carrier status; 14. History of alcohol abuse, drug abuse, or psychiatric illness; 15. Participation in any other clinical study within 3 months prior to enrollment in this clinical study; 16. Female subjects who meet any of the following conditions: 1. Pregnant or breastfeeding; 2. Planning to become pregnant during the study; or 3. Of childbearing potential and unwilling or unable to use effective contraception; 17. Any other condition that, in the investigator's opinion, makes the subject unsuitable for participation in this study.