Study of Relapsed/ Refractory B-cell Non- Hodgkin Lymphoma

Exclusion Criteria28

• Participants with ANY of the following criteria are excluded from participation in the study:
• Histologically documented primary CNS lymphoma, CLL, Burkitt, Burkitt-like lymphoma.
• Known hypersensitivity or allergy to any component of the study medications, including sulfa-containing study medication(s) (e.g., albumin \[human\], dimethyl sulfoxide \[DMSO\]).
• Inadequate organ function, evidenced by the following laboratory results:
• ANC \< 1000 cells/mm3.
• Platelet count \< 100,000 cells/mm3.
• Total bilirubin ≥ 1.5 × the upper limit of normal (ULN; unless the participant has documented Gilbert's syndrome or indirect hyperbilirubinemia).
• Aspartate aminotransferase (AST \[SGOT\])/ALT (SGPT) ≥ 2.5 × ULN.
• Alkaline phosphatase (ALP) levels ≥ 2.5 × ULN (or ≥ 5 × ULN in participants with bone metastases).
• Serum creatinine ≥ 160 µmol/L. NOTE: Each study site should use its institutional ULN to determine eligibility.
• Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the participant at high risk for treatment-related complications.
• History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon: such as systemic lupus erythematous, Wegner's glomerulonephritis, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura requiring steroid therapy defined as \> 20 mg of prednisone or equivalent daily.
• History of allogeneic hematopoietic stem-cell transplantation (HSCT) requiring ongoing systemic graft versus host disease (GvHD) therapy.
• Anti-CD20 antibody treatment less than 2 weeks prior to cell infusion.
• History of receiving allograft organ transplant requiring immunosuppression.
• Participants post solid organ transplants who develop high grade lymphomas or leukemias.
• Metastases to the CNS, including parenchyma or leptomeninges.
• Nonmalignant CNS disease (e.g., stroke, epilepsy, vasculitis, or neurodegenerative disease).
• History of active inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
• Uncontrolled hypertension (systolic \> 160 mm Hg and/or diastolic \> 110 mm Hg) or clinically significant (i.e., active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association (Appendix 6) Class 2 or higher; or serious cardiac arrhythmia requiring medication.
• Current chronic daily treatment (continuous for \>3 months) with systemiccorticosteroids as defined as \>20 mg of prednisone or equivalent daily, excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in participants who have known contrast allergies is allowed.
• Currently taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
• Tested positive for tuberculosis (TB) utilizing the QuantiFERON Gold TB test.
• History of human immunodeficiency virus (HIV) with current CD4+ T-cell count \< 350 cells/μL and a detectable HIV viral load.
• Known carriers of hepatitis B virus (HBV) infection that is currently hepatitis B surface antigen (HBsAg) positive.
• Concurrent active malignancy other than basal or squamous cell carcinomas of the skin.
• Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
• Women who are pregnant or breastfeeding.