UPCC 27424 Expanded Access Study for the Treatment of Patients with Commercially Out-of-Specification Axicabtagene Ciloleucel

Investigational Access to Out-of-Specification Investigational Medication

Enrolling By Invitation
18 years or above
All
Phase N/A
1 Location

Brief description of study

The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Large B-cell Lymphoma, Follicular Lymphoma
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  • Have commercially manufactured axicabtagene ciloleucel that does not meet commercial release criteria but does meet Kite clinical trial release criteria
  • Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been post-menopausal for at least 2 years are not considered to be of childbearing potential)
  • Deemed medically fit and stable to receive the product per the investigator's evaluation
  • Repeat leukapheresis is not feasible per the investigator's assessment
  • Be diagnosed with 1 of the approved labeled indications for axicabtagene ciloleucel that is intended for release
  • In the investigator's opinion, there is no satisfactory alternative therapy available to the individual

Exclusion Criteria:

  • History of severe immediate hypersensitivity to any drugs or metabolites of similar chemical classes as axicabtagene ciloleucel
  • Uncontrolled active infection or inflammation per physician assessment
  • Primary central nervous system lymphoma

This study investigates providing access to axicabtagene ciloleucel, an investigational medication, for patients who have a disease approved for treatment with this medication but whose product does not meet commercial release criteria. The purpose is to allow patients to receive treatment with axicabtagene ciloleucel that is otherwise unavailable due to commercial specifications.

Participants will receive axicabtagene ciloleucel that meets clinical trial release criteria but not commercial release criteria. They must be medically fit and stable to receive the investigational medication, and repeat leukapheresis must not be feasible. Females of childbearing potential must have a negative pregnancy test before participation.

  • Who can participate: Adults with a disease approved for treatment with the investigational medication, who have the product meeting clinical trial but not commercial release criteria, and are medically fit without satisfactory alternative therapy can participate.
  • Study details: Participants will receive investigational medication that is out-of-specification for commercial release but meets clinical trial criteria. They must be stable and able to receive treatment, with no option for repeat leukapheresis.
Updated on 12 Jun 2026. Study ID: 24-0836
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