Clinical Trial of HY004 Cell Injection in the Treatment of Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

Exclusion Criteria

• •1. Active Central Nervous System (CNS) involvement by malignancy.
• •2. Patients with existing central nervous system disease or with a history of central nervous system disease.
• •3. Patients receiving any of the following drugs or therapies within the specified period prior to apheresis:
• •1. Alemtuzumab and Bendamustine within 6 months prior to apheresis;
• •2. Cladribine within 3 months prior to apheresis;
• •3. Lenalidomide within 1 mouth prior to apheresis;
• •4. Lymphocytotoxic chemotherapy within 2 weeks prior to apheresis - use in more than 3 half-lives prior to apheresis is eligible;
• •5. Anti-CD20 monoclonal antibody and therapeutic dose of hormones within 7 d prior to apheresis;
• •6. Non-lymphocytotoxic chemotherapy within 7 d prior to apheresis - use in more than 3 half-lives prior to apheresis is eligible;
• •7. Venetoclax (BCL-2 inhibitor) within 4 d prior to apheresis;
• •8. Idelalisib (PI3Kδ kinase inhibitor) within 2 d prior to apheresis;
• •9. DLI within 6 weeks prior to apheresis;
• •10. Radiotherapy within 6 weeks prior to apheresis - progressive disease at radiotherapy site, or PET positive lesion at other non-radiotherapy site is eligible;
• •4. Patients previously received CAR-T cell therapy, the products that have same indication and have beenlisted in China are eligible;
• •5. Patients who have previously received allogeneic hematopoietic stem cell transplantation (allo-HSCT) within 3 mouths.
• •6. Patients with acute graft-versus-host disease (GVHD) or moderate-tosevere chronic GVHD within 4 weeks before screening.
• •7. Active systemic autoimmune disease.
• •8. Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti- HCV positive).
• •9. Patients with active infections at screening.
• •10. History of cardiovascular disease.
• •11. Pregnant or nursing women.