Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma

Inclusion Criteria

• •1. Histologically confirmed:
• •* Diffuse Large B Cell Lymphoma (DLBCL)
• •* Primary Mediastinal Large B Cell Lymphoma (PMBCL)
• •* Transformation Follicular Lymphoma (TFL)
• •* High grade B-cell lymphoma (HGBCL)
• •2. Chemotherapy-refractory disease, defined as one of more of the following:
• •* No response to last line of therapy i. Progressive disease (PD) as best response to most recent therapy regimen ii. Stable disease (SD) as best response to most recent therapy with duration no longer than 6 month from last dose of therapy OR
• •* Refractory post-autologous stem cell transplant (ASCT) i. Disease progression or relapsed less than or equal to 12 months of ASCT (must have biopsy proven recurrence in relapsed individuals) ii. If salvage therapy is given post-ASCT, the individual must have had no response to or relapsed after the last line of therapy
• •3. Individuals must have received adequate prior therapy including at a minimum:
• •* Anti-cluster of differentiate 20 (CD20) monoclonal antibody unless investigator determines that tumor is CD20-negative and
• •* an anthracycline containing chemotherapy regimen
• •* for individual with transformed FL must have chemorefractory disease after transformation to DLBCL.
• •4. At least one measurable lesion per revised international working group (IWG Response Criteria
• •5. Eastern cooperative oncology group (ECOG) performance status of 0 or 1
• •6. Absolute neutrophil count (ANC) ≥ 1000/microliters (uL)
• •7. Absolute lymphocyte count ≥ 100/uL
• •8. Platelet count ≥ 75,000/uL
• •9. Adequate renal, hepatic, pulmonary and cardiac function defined as:
• •* Creatinine clearance (as estimated by Cockcroft Gault) \> 60 mL/min
• •* Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \< 2.5 upper limit of normal (ULN)
• •* Total bilirubin \< 1.5 mg/dL, except in individuals with Gilbert's syndrome
• •* Cardiac ejection fraction \>50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant pleural effusion
• •* Baseline oxygen saturation \>92% on room air
• •10. All individuals or legally appointed representatives/caregivers, must personally sign and date the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent form before initiating any study specific procedures or activities.
• •11. Relapsed or refractory large B-cell lymphoma including DLBCL, PMBCL, TFL, and HGBCL after two systemic lines of therapy