Expanded Access Protocol (EAP) for Subjects Receiving Lisocabtagene Maraleucel That is Nonconforming for Commercial Release
This is an expanded access protocol that will be conducted at sites qualified and approved to treat patients with lisocabtagene maraleucel. Sometimes when lisocabtagene maraleucel is manufactured the drug does not pass all the testing results to be called lisocabtagene maraleucel. When this happens the drug is called nonconforming lisocabtagene maraleucel. The expanded access protocol will be used to allow patients to receive nonconforming lisocabtagene maraleucel only if the potential benefit is better than the potential risk. This expanded access protocol is restricted to those patients who were prescribed lisocabtagene maraleucel as part of their routine care. Patients will first receive a lymphodepleting chemotherapy regimen and then be treated with nonconforming lisocabtagene maraleucel as the treatment plan.
Primary Objective: The primary objective of the study is to assess the safety of nonconforming lisocabtagene maraleucel in patients. Secondary Objective: The secondary objective of the study is to assess the efficacy of nonconforming lisocabtagene maraleucel in patients. Exploratory Objective: Exploratory objectives of the study are to assess duration of response (DOR), progression-free survival (PFS), and overall survival (OS).
cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate); lisocabtagene maraleucel ()
- Inclusion Criteria:
- Patient and/or LAR must understand and voluntarily sign an informed consent form prior to any study-related assessments/procedures being conducted.
- Patient has relapsed and/or refractory large B-cell lymphoma and is, per the treating physician assessment, eligible for treatment with lisocabtagene maraleucel per the approved prescribing information.
- Patient is at least18 years of age at the time of signing the informed consent form.
- Patient had a specific batch of lisocabtagene maraleucel manufactured intended for commercial treatment; however, the final manufactured product did not meet commercial release criteria.
- Remanufacturing (eg, repeat leukapheresis and manufacturing) is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the patient.
- Patient is clinically stable, has recovered from any toxicities prior to receiving lymphodepleting chemotherapy, and has adequate bone marrow function to receive lymphodepleting chemotherapy. The treating physician is advised to contact Medical Monitor in the event there is any concern regarding administration of lymphodepleting chemotherapy.
- Females of childbearing potential must: (a) 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 patient practices true abstinence from heterosexual contact. (b) 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 lisocabtagene maraleucel administration. (c) Agree to abstain from breastfeeding during study participation and for at least 12 months following nonconforming lisocabtagene maraleucel administration. (d) There are insufficient exposure data to provide any recommendation concerning the duration of contraception and the abstaining from breastfeeding following treatment with lisocabtagene maraleucel. Any decision regarding contraception and breastfeeding after infusion should be discussed with the treating physician.
- Male patients must: (a) 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 lisocabtagene maraleucel administration even if the patient has undergone a successful vasectomy. (b) There are insufficient exposure data to provide any recommendation concerning the duration of contraception following treatment with lisocabtagene maraleucel. Any decision regarding contraception after infusion should be discussed with the treating physician (c) Patient 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 lisocabtagene maraleucel administration.
- Additional criteria may apply
- Exclusion Criteria:
- Patient has a hypersensitivity to the active substance or to any of the excipients.
- Patient should not experience a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of adverse events associated with lymphodepleting chemotherapy, or exclude them from treatment with nonconforming lisocabtagene maraleucel.
- Patient has any significant medical condition, laboratory abnormality, or psychiatric illness, sociologic or geographic condition that would prevent the patient from participating in the Expanded Access Protocol complying with protocol requirements in the Investigator's judgement.
- Patient has any condition and/or laboratory abnormality that places the patient at unacceptable risk if he/she were to participate in the Expanded Access Protocol based on the Investigator's judgement
- Pregnant or nursing women or has intention of becoming pregnant during the study.
- Patients with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study).
- Patient has active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection at the time of pretreatment evaluation
- Patient has uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of nonconforming lisocabtagene maraleucel administration.
- Patient has presence of acute or chronic graft-versus-host disease (ie, GVHD)
- Use of the following: (a) Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 72 hours prior to nonconforming lisocabtagene maraleucel administration. Physiologic replacement, topical, and inhaled steroids are permitted. (b) Low dose chemotherapy (eg, vincristine, rituximab, cyclophosphamide ≤ 300 mg/m2)given after leukapheresis to maintain disease control must be stopped ≥ 7 days prior to lymphodepleting chemotherapy. (c) Cytotoxic chemotherapeutic agents that are not considered lymphotoxic (see below) within 1 week of LD chemotherapy. Oral chemotherapeutic agents, including lenalidomide and ibrutinib, are allowed if at least 3 half-lives have elapsed prior to lymphodepleting chemotherapy. (d) Donor lymphocyte infusions within 6 weeks of nonconforming lisocabtagene maraleucel administration.
- Other criteria may apply
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