UPCC 28424 Expanded Access Study for the Treatment of Patients with Commercially Out-of-Specification Brexucabtagene Autoleucel

Access to Investigational Therapy: Brexucabtagene Autoleucel for Patients with Specific Conditions

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 brexucabtagene autoleucel for patients diagnosed with a disease approved for treatment with brexucabtagene autoleucel, 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: Mantle Cell Lymphoma, Acute Lymphoblastic Leukemia
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  • Have commercially manufactured brexucabtagene autoleucel 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 brexucabtagene autoleucel 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 brexucabtagene autoleucel
  • Uncontrolled active infection or inflammation per physician assessment
  • Primary central nervous system (CNS) lymphoma

This study investigates the use of an investigational therapy for patients who have been diagnosed with a condition approved for treatment with this therapy, but whose therapy does not meet commercial release criteria. The purpose is to provide access to this investigational treatment under specific conditions.

Participants in this study will receive the investigational therapy that has met clinical trial release criteria but not commercial release criteria. The study will include evaluations to ensure participants are medically fit and stable to receive the treatment.

  • Who can participate: Adults who have a condition approved for treatment with the investigational therapy and have therapy that meets clinical trial release criteria but not commercial release criteria may participate. Women of childbearing potential must test negative for pregnancy. Participants must be deemed medically fit and have no satisfactory alternative therapy.
  • Study details: Participants will receive an investigational therapy that has met clinical trial release criteria. Evaluations will be conducted to ensure medical fitness for receiving the treatment.
Updated on 08 Apr 2026. Study ID: 24-0835
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