CTL019 Out of Specification MAP for ALL or DLBCL Patients

Open to people ages up to 25 years

• Written informed consent must be obtained prior to any screening procedures or treatment assignment.
• Has a patient specific batch of CTL019 which is out of specification either due to out of specification incoming apheresis or final product not meeting commercial release.
• Not excluded from commercial manufacturing under the prescribing guidelines for their country
• Out of specification material has not been deemed to pose an undue safety risk to the patient
• Is suffering from a serious or life-threatening disease or condition
• Repeat leukapheresis is not feasible per the treating physician assessment
• Does not have access to a comparable or satisfactory alternative treatment
• Is not eligible for participation in any of the IMP's ongoing clinical trials or has recently completed a clinical trial that has been terminated and, after considering other options, the clinical team has determined that treatment is necessary and there are no other feasible alternatives for the patient
• Meets any other relevant medical criteria for compassionate use of the investigational product
• Is not being transferred from an ongoing clinical trial for which they are still eligible

• Product can be commercially manufactured per the specification of the country in which treatment will occur.
• Patients who are able to repeat leukapheresis.
• Evidence of CD19 negative disease
• HIV positive patients
• Patients with active replication of Hep B or active or latent Hep C
• History of hypersensitivity to any drugs or metabolites of similar chemical classes as tisagenlecleucel.
• Uncontrolled active infection or inflammation
• History of unstable angina or MI within 6 months prior to screening
• Any medical condition identified by the investigator that may impact the assessment of the safety or efficacy outcomes in relation to study treatment