CTA101 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma

Exclusion Criteria

• •1. History of hypersensitivity to any component of cell product;
• •2. Prior treatment with any CAR T cell product or other genetically-modified T cell therapies;
• •3. Recurrence after allogeneic hematopoietic stem cell transplantation;
• •4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis), or currently receiving antibiotic therapy by intravenous drip. However, prophylactic antibiotic, antiviral and antifungal treatments are allowed;
• •5. HBV DNA copy number detected by PCR in patients with active hepatitis B is \> 1000 at screening (if HBsAg positive, routine antiviral therapy is required after enrollment), as well as CMV, hepatitis C, syphilis and HIV infection;
• •6. Patients with New York Heart Associate (NYHA) Class III/IV cardiac insufficiency (see Appendix 1);
• •7. Patients with Corrected QT interval(QTc)\>450 msecs (Fridericia formula);
• •8. Patients with a history of epilepsy;
• •9. Intracranial extranodal lesions (tumor cells in cerebrospinal fluid, and/or MRI shows intracranial lymphoma invasion);
• •10. Extensive invasions of gastrointestinal lymphoma (lesions involving the muscular layer, serosa and subserosa, excluding lesions confined to the mucosa and submucosa);
• •11. History of other primary cancer, except for the following conditions:
• •1. Cured non-melanoma after resection, such as basal cell carcinoma of the skin
• •2. Cured carcinoma in situ, such as cervical cancer, bladder cancer or breast cancer
• •12. Patients with autoimmune diseases requiring treatment, patients with immunodeficiency or requiring immunosuppressive therapy;
• •13. Concurrent therapy with systemic steroids within 1 week prior to screening, except for the patients recently or currently receiving inhaled steroids;
• •14. Women pregnant or lactating, with a pregnancy plan within 6 months, fertile but unable to take medically acceptable contraception measures;
• •15. Patients who have participated in any other clinical studies within 2 weeks prior to screening;
• •16. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.