Study of Out of Specification for Tisagenlecleucel

Key inclusion criteria: * Signed informed consent/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 exclusion criteria: 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 CTL0…