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.
Full Title of Study: “Expanded Access Protocol (EAP) for Patients Receiving Lisocabtagene Maraleucel That is Nonconforming for Commercial Release.”
- Study Type: Expanded Access
- Biological: Nonconforming Lisocabtagene Maraleucel
- Nonconforming lisocabtagene maraleucel is lisocabtagene maraleucel that does not meet the commercial release specifications, however is deemed acceptable to administer as an investigational product in the Expanded Access Protocol setting.
Participating in This Clinical Trial
1. Patient must understand and voluntarily sign an informed consent form prior to any study-related assessments/procedures being conducted.
2. Patient is ≥ 18 years of age at the time of signing the informed consent form.
3. Patient had a patient-specific batch of lisocabtagene maraleucel manufactured intended for commercial treatment; however, the final manufactured product was nonconforming and did not meet commercial release criteria.
4. Remanufacturing (eg, repeat leukapheresis and manufacturing) is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the patient.
5. Patient meets any other relevant medical criteria for lymphodepleting chemotherapy and infusion of a cellular therapy product as per Investigator's clinical judgement.
6. 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 patient 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 lisocabtagene maraleucel administration.
3. Agree to abstain from breastfeeding during study participation and for at least 12 months following nonconforming lisocabtagene maraleucel administration.
4. 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.
7. Male patients 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 lisocabtagene maraleucel administration even if the patient has undergone a successful vasectomy.
2. 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
8. 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.
1. Patient has a hypersensitivity to the active substance or to any of the excipients.
2. Patient has a contraindication to lymphodepleting chemotherapy.
3. 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.
4. Patient has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the Expanded Access Protocol or complying with protocol requirements in the Investigator's judgement.
5. 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
- Lead Sponsor
- Juno Therapeutics, a Subsidiary of Celgene
- Provider of Information About this Clinical Study
- Overall Official(s)
- Mecide Gharibo, MD, Study Director, Celegene/BMS
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