Study of Out of Specification for Tisagenlecleucel

Key inclusion criteria:

• Signed informed consent/assent must be obtained for this study prior toparticipation in the study.

• Patients for whom the final manufactured tisagenlecleucel product does not meet thecommercial release specifications.

• Not excluded from commercial manufacturing under the Health Authority-approvedtisagenlecleucel 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 classesas tisagenlecleucel.

• Uncontrolled active infection or inflammation.

• Any medical condition identified by the investigator that may impact the assessmentof 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 versionsof the package insert of CTL019.