CD180 CART for Relapsed or Refractory CD180 Positive Hematologic Malignancies

Exclusion Criteria

• •Subjects who met any of the following criteria were excluded from the study:
• •1. acute promyelocytic leukemia (APL);
• •2. Presence of a genetic syndrome such as Fanconi's anemia, Kostmann's syndrome, Shwachman syndrome or any other known syndrome of bone marrow failure;
• •3. Patients with uncontrolled active central nervous system leukemia (CNSL), i.e. cerebrospinal fluid grades CNS 2 and CNS 3;
• •4. Patients who have received anti-tumor therapy before infusion should be excluded if any of the following conditions are met:
• •1. Systemic chemotherapy (except for pretreatment) within 1 week;
• •2. For those who have received monoclonal antibody therapy, the last time of monoclonal antibody infusion is less than 5 half-lives or 4 weeks (whichever is shorter) at screening;
• •3. Received donor lymphocyte infusion (DLI) within 6 weeks;
• •5. Presence of uncontrolled, serious, active infection at screening;
• •6. Patients with a history of serious heart disease, including: severe cardiac insufficiency (subjects with cardiac insufficiency of Class III or IV according to the New York Heart Association (NYHA) cardiac function classification standard), myocardial infarction within 12 months or cardiac angioplasty or stenting, unstable angina pectoris, ECG indicating significant QT interval prolongation (\>480ms) or serious arrhythmia judged by the investigator;
• •7. Previous craniocerebral trauma, disturbance of consciousness, epilepsy, cerebral ischemia, cerebral vascular hemorrhagic disease and other medical history, and within six months of the need for drug treatment;
• •8. Patients with hepatitis B surface antigen (HBsAg) greater than 10E6 IU/mL, hepatitis C virus (HCV) antibody positive, human immunodeficiency virus (HIV) antibody positive, syphilis antibody test positive, EBER positive or EBV copy number greater than the upper limit of normal at screening;
• •9. Patients who must use steroid hormones during CAR-T infusion (except for local or inhaled steroid hormones); subjects who are receiving systemic steroid therapy before screening and need long-term systemic steroid therapy during treatment according to the investigator's judgment (except for inhaled or local use);
• •10. Subjects with autoimmune diseases requiring treatment, immunodeficient subjects, or subjects requiring immunosuppressive treatment;
• •11. Patients with acute graft-versus-host disease (GvHD) or moderate-to-severe chronic GvHD within 4 weeks prior to screening;
• •12. Patients with a history of allergy to any component of cell products;
• •13. Pregnant, lactating females, and subjects (male or female) of childbearing potential who are unable to use effective contraception within 1 year after cell infusion; male subjects who plan to become pregnant within 1 year after cell infusion; female subjects or partners who plan to become pregnant within 1 year after cell infusion;
• •14. Any condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the results of the trial.