Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma

Exclusion Criteria

• •1. Patients with active central nervous system (CNS) lymphoma (a patient with CNS disease symptoms must receive lumbar puncture and MRI/CT to exclude CNS lymphoma).
• •2. Patients with existing central nervous system disease or with a history of central nervous system disease, e.g., epileptic seizure, cerebral ischemia/hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellum disease, organic brain syndrome, mental disease, or any autoimmune disease involved with central nervous system.
• •3. Patients receiving any of the following drugs or therapies within the specified period prior to apheresis:
• •* Alemtuzumab within 6 months prior to apheresis;
• •* Cladribine within 3 months prior to apheresis;
• •* Anti-CD20 monoclonal antibody within 7 d prior to apheresis;
• •* Venetoclax (BCL-2 inhibitor) within 4 d prior to apheresis;
• •* Idelalisib (PI3Kδ kinase inhibitor) within 2 d prior to apheresis;
• •* Lenalidomide within 1 d prior to apheresis;
• •* Lymphocytotoxic chemotherapy within 2 weeks prior to apheresis - use in more than 3 half-lives prior to apheresis is eligible;
• •* Non-lymphocytotoxic chemotherapy within 7 d prior to apheresis - use in more than 3 half-lives prior to apheresis is eligible;
• •* Radiotherapy within 6 weeks prior to apheresis, including big bone marrow area (e.g., sternum or pelvis) - progressive disease at radiotherapy site, or PET positive lesion at other non-radiotherapy site is eligible; if there is existing PET positive lesion in other non-radiotherapy sites, then it is allowable to conduct radiotherapy at a single lesion within 2 weeks prior to apheresis.
• •4. Patients receiving chemotherapy within 2 weeks prior to CNCT19 Cell injection infusion, excluding the following conditions:
• •* Pretreatment chemotherapy as specified by the protocol;
• •* CNS lymphoma prophylaxis by intrathecal injection (it must be stopped within 1 week prior to infusion of CNCT19 Cell Injection).
• •5. Discontinuation of a systematic therapeutic hormone within 72 h prior to infusion of CNCT19 Cell Injection; however, use of the hormone in the physiological surrogate amount is eligible (e.g., Prednisone in a dose of \<10 mg/d or equivalent).
• •6. Patients previously received CAR-T cell therapy.
• •7. Patients who have previously received allogeneic hematopoietic stem cell transplantation (allo-HSCT).
• •8. Patients with known active or uncontrolled synstemic autoimmune disease and under treatment.
• •9. Patients complying with any of hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg) positive, hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab) positive and HBV-DNA copies being more than the lower limit of detection, hepatitis C antibody (HCV-Ab) positive, anti-treponemia pallidum antibody (TP-Ab) positive, EBV-DNA, and CMV-DNA copies being more than the lower limit of detection.
• •11. Patients with concurrent active malignancy; those with a history of malignancy, cured for≥2 years, are eligible.
• •12. Patients complying any of the following conditions: Left ventricular ejection fraction (LVEF) ≤45% (ECHO); New York Heart Association (NYHA) Grade III or IV congestive heart failure; Uncontrolled hypertension (systolic blood pressures≥140mmHg and/or diastolic blood pressures ≥90 mmHg), pulmonary hypertension, or unstable angina pectoris; Myocardial infarction or bridging or stent procedure within 12 months prior to administration of the drug; Clinically significant valvular heart disease; Other heart diseases unsuitable for enrollment, as judged by the investigator.
• •13. Patients with lymphoma involved with atrium or ventricle.
• •14. Patients with clinical emergency (e.g., intestinal infarction or vascular compression) requiring treatment, due to existing lymphoma body obstruction or compression at screening.
• •15. Patients with active hemorrhage at screening.
• •16. Patients with deep vein thrombosis within 6 months prior to screening, or a history of pulmonary embolism.
• •17. Patients who are known with a history of hypersensitivity reaction to any ingredient used for the drug product in the trial.
• •18. Patients vaccinated with a live vaccine within 6 weeks prior to screening.
• •19. Patients with active infection at screening.
• •20. Patients with a life expectancy of less than 3 months.
• •21. Patients participating in any other interventional clinical study or receiving treatment of an active investigational drug within 3 half-lives prior to CNCT19 Cell Injection infusion.