Expanded Access Study for Patients Needing Axicabtagene Ciloleucel Treatment

Sponsor: Kite, A Gilead Company

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05776160

Provider View

This study aims to provide access to a specific treatment, axicabtagene ciloleucel, for patients who need it but whose treatment does not meet the usual commercial standards.

Patient Parameters

Program Overview

The purpose of this study is to offer axicabtagene ciloleucel, a treatment for certain diseases, to patients who qualify for it but whose treatment does not meet the usual commercial standards. This allows patients to receive the treatment even if it is not available commercially.

Eligibility Criteria

Inclusion Criteria

  • Have axicabtagene ciloleucel that doesn't meet commercial standards but is approved for clinical trials.
  • Women who can have children must test negative for pregnancy unless they are surgically sterilized or have been menopausal for at least two years.
  • Must be considered medically fit and stable to receive the treatment according to the doctor's evaluation.
  • Cannot undergo another leukapheresis procedure, as determined by the doctor.
  • Must have a diagnosis that is approved for treatment with axicabtagene ciloleucel.
  • No other satisfactory treatment options available, according to the doctor.

Exclusion Criteria

  • Have a history of severe allergic reactions to similar drugs.
  • Have an uncontrolled active infection or inflammation, as assessed by a doctor.
  • Have primary central nervous system lymphoma.

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