Expanded Access Program for Nonconforming Lisocabtagene Maraleucel Treatment

Sponsor: Juno Therapeutics, a Subsidiary of Celgene

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04400591

Provider View

This program allows patients to receive a special version of the cancer treatment lisocabtagene maraleucel, which didn't meet all the usual standards but may still offer benefits. It's for patients who were already prescribed this treatment as part of their regular care.

Patient Parameters

Program Overview

This program provides access to a version of the cancer treatment lisocabtagene maraleucel that didn't pass all the standard tests but might still be beneficial. Patients will first receive chemotherapy to prepare their body, followed by the nonconforming lisocabtagene maraleucel. This option is only available if the potential benefits outweigh the risks, and it's for patients who were already prescribed this treatment as part of their routine care.

Eligibility Criteria

Inclusion Criteria

  • Must understand and sign a consent form before any study procedures.
  • Must have been prescribed lisocabtagene maraleucel for an approved diagnosis.
  • Must be 18 years or older.
  • Must have a batch of lisocabtagene maraleucel that didn't meet commercial standards.
  • Remanufacturing the treatment is not possible or appropriate.
  • Must be clinically stable and have recovered from any previous treatment side effects.
  • Must have adequate bone marrow function for chemotherapy.
  • Women of childbearing potential must:
    • Have a negative pregnancy test before starting chemotherapy.
    • Agree to use effective birth control or abstain from heterosexual contact for at least 12 months after treatment.
    • Agree not to breastfeed during the study and for 12 months after treatment.
  • Men must:
    • Agree to use a condom during sexual contact for at least 12 months after treatment.
  • Must agree not to donate blood, organs, or reproductive cells for at least 1 year after treatment.

Exclusion Criteria

  • Allergic to the treatment or its ingredients.
  • Significant worsening of health that increases risk with chemotherapy or treatment.
  • Any medical, psychiatric, or social condition that prevents participation.
  • Any condition that poses an unacceptable risk during the program.
  • Pregnant or nursing women, or those planning to become pregnant.
  • Primary central nervous system lymphoma (secondary involvement is allowed).
  • Uncontrolled hepatitis B, C, or HIV infection.
  • Uncontrolled infections despite treatment.
  • Active graft-versus-host disease.
  • Receiving other cancer treatments that increase risk or interfere with the program.

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