A Study to Evaluate the Safety and Effectiveness of Lisocatagene Maraleucel in Patients

Overview

About this study

The purpose of this study is to assess the safety of nonconforming lisocabtagene maraleucel in patients, and to assess the effectiveness of nonconforming lisocabtagene maraleucel in patients.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patient must understand and voluntarily sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures being conducted.
  • Patient is ≥ 18 years of age at the time of signing the ICF.
  • 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. The Sponsor Internal Review Process has determined that the nonconforming lisocabtagene maraleucel may be released for use under the EAP.
  • Remanufacturing (e.g., repeat leukapheresis and manufacturing) is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the patient.
  • Patient meets any other relevant medical criteria for LD chemotherapy and infusion of a cellular therapy product as per Investigator’s clinical judgement.
  • Females of childbearing potential (FCBP*) must:
    • Have a negative pregnancy test as verified by the treating physician within 7 days prior to the first dose of lymphodepleting (LD) chemotherapy following institutional testing methodology practices. This applies even if the patient practices true abstinenceb from heterosexual contact;
    • 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;
    • Agree to abstain from breastfeeding during study participation and for at least 12 months following nonconforming lisocabtagene maraleucel administration.
  • 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:
    • 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;
    • 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.
  • 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. There are insufficient exposure data to provide any recommendation concerning the duration of refraining from tissue donation following treatment with lisocabtagene maraleucel; therefore, patients treated with lisocabtagene maraleucel should not donate blood, organs, tissues, and cells for transplantation.

*  A female patient of childbearing potential (FCBP) is a female who:

  • has achieved menarche at some poin;
  • has not undergone a hysterectomy or bilateral oophorectomy; or
  • has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

** True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the patient. In contrast, periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.

Exclusion Criteria:

  • Patient has a hypersensitivity to the active substance or to any of the excipients.
  • Patient has a contraindication to lymphodepleting chemotherapy.
  • Patient should not experience a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of AEs associated with LD chemotherapy, or exclude them from treatment with nonconforming lisocabtagene maraleucel.
  • Patient has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the EAP or 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 EAP based on the Investigator’s judgement.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Mohamed Kharfan Dabaja, M.D., M.B.A.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Patrick Johnston, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20507055

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