Study of Out of Specification for Tisagenlecleucel

Key Who May Qualify: - Signed willing to sign a consent form/assent must be obtained for this study prior to participation in the study. - Patients for whom the final manufactured tisagenlecleucel product does not meet the commercial release specifications. - Not excluded from commercial manufacturing under the Health Authority-approved tisagenlecleucel prescribing information for their respective country/region. - OOS material has not been deemed to pose an undue safety risk to the patient. - Patient is suffering from a serious or life-threatening disease or condition. - Repeat leukapheresis is not clinically appropriate per the investigator assessment. Key Who Should NOT Join This Trial: For part 1, patients meeting any of the following criteria are not eligible for inclusion in this study: - Human immunodeficience virus (HIV) positive patients. - Patients with active replication of Hepatitis B virus (HBV) or Hepatitis C virus (HCV). - Patients with primary central nervous system (CNS) lymphoma. - History of hypersensitivity to any drugs or metabolites of similar chemical classes as tisagenlecleucel. - Uncontrolled active infection or inflammation. - Any medical condition identified by the investigator that may impact the assessment of the safety or efficacy outcomes in relation to study treatment. - Pregnant or nursing (lactating) women. For part 2, exclusion criteria are not set; however, administration should be performed in accordance with the latest versions of the package insert of CTL019. Always talk to your doctor about whether this trial is right for you.