Study of Out of Specification for Tisagenlecleucel

Más betegség

• Human immunodeficience virus (HIV) positive patients.
• Patients with active replication of Hepatitis B virus (HBV) or Hepatitis C virus (HCV).
• 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.

Egyéb

• For part 1, patients meeting any of the following criteria are not eligible for inclusion in this study:
• Patients with primary central nervous system (CNS) lymphoma.
• 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.

• 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.