Relmacabtagene Autoleucel As Second-Line Therapy in Adult Patients with Aggressive B-cell NHL

Exclusion Criteria

• •6. Adequate organ function;
• •7. Presence of positive PET assessable lesions as determined by the Lugano criteria ;
• •8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
• •9. Expected survival greater than 12 weeks;
• •10. Adequate vascular access for leukapheresis procedure;
• •11. Women of childbearing potential must agree to use highly effective methods of contraception for at least 28 days prior to lymphocyte clearance chemotherapy through 2 year after Relmacabtagene Autoleucel infusion; Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 2 year after Relmacabtagene Autoleucel infusion;
• •1. Subjects with non-Hodgkin's lymphoma who have received second or more line therapy;
• •2. Lymphoma of the primary center (subjects with secondary central nervous system lymphoma are allowed to enroll;
• •3. History of another primary malignancy that has not been in remission for at least 2 years;
• •4. Subjects has active HBV, HCV, HIV or syphilis infection at the time of screening;
• •5. Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;
• •6. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection;
• •7. Uncontrolled diabetes and hypertension;
• •8. Presence of acute or chronic graft-versus-host disease (GVHD);
• •9. Active autoimmune disease requiring immunosuppressive therapy;
• •10. History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;
• •11. Pregnant or nursing women;
• •12. Subjects Received an autologous or allogeneic hematopoietic stem cell transplant;
• •13. Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;
• •14. Received CAR T-cell or other genetically-modified T-cell therapy previously;
• •15. Received live vaccination within 6 weeks prior to lymphocyte clearance chemotherapy;
• •16. History of severe hypersensitivity reactions to any of the drug ingredients used in this study product.