Nonconforming Lisocabtagene Maraleucel Expanded Access Protocol

Inclusion Criteria

• •1. Subject and/or LAR must understand and voluntarily sign an informed consent form prior to any study-related assessments/procedures being conducted.
• •2. Subject was prescribed lisocabtagene maraleucel (liso-cel) for a diagnosis that is approved per local prescribing information, per treating physician assessment.
• •3. Subject is ≥ 18 years of age at the time of signing the informed consent form.
• •4. Subject had a subject-specific batch of liso-cel manufactured intended for commercial treatment; however, the final manufactured product did not meet the local commercial release criteria.
• •5. Remanufacturing (eg, repeat leukapheresis and manufacturing) is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the subject.
• •6. Subject is clinically stable, has recovered from any prior toxicities which places the subject at clinical risk prior to receiving LD chemotherapy, and has adequate bone marrow function to receive LD chemotherapy. The treating physician is advised to contact the Medical Monitor in the event there is any concern regarding administration of LD chemotherapy.
• •7. Females of childbearing potential must:
• •1. Have a negative pregnancy test as verified by the treating physician within 7 days prior to the first dose of lymphodepleting chemotherapy following institutional testing methodology practices. This applies even if the subject practices true abstinence from heterosexual contact.
• •2. Either commit to true abstinence from heterosexual contact or agree to use, and be able to comply with, effective contraception without interruption. Contraception methods must include 1 highly effective method from screening until at least 12 months after the nonconforming liso-cel administration.
• •3. Agree to abstain from breastfeeding during study participation and for at least 12 months following nonconforming liso-cel administration.
• •4. There are insufficient exposure data to provide any recommendation concerning the duration of contraception and the abstaining from breastfeeding following treatment with liso-cel. Any decision regarding contraception and breastfeeding after infusion should be discussed with the treating physician.
• •8. Male subjects must:
• •1. Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential for at least 12 months after nonconforming liso-cel administration even if the subject has undergone a successful vasectomy.
• •2. There are insufficient exposure data to provide any recommendation concerning the duration of contraception following treatment with liso-cel. Any decision regarding contraception after infusion should be discussed with the treating physician
• •9. Subject must agree to not donate blood, organs, tissue, sperm or semen and egg cells for usage in other individuals for at least 1 year following nonconforming liso-cel administration.