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Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel

Status
Active
Cancer Type
Leukemia
Lymphoma
Trial Phase
Eligibility
18 Years and older (Adult, Older Adult ), Male and Female
Study Type
NCT ID
NCT05776134
Protocol IDs
KT-US-472-0141 (primary)
Study Sponsor
Gilead Sciences (Kite, A Gilead Company)

Summary

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.

  • Biological: Brexucabtagene Autoleucel
    • A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg administered intravenously.
    • Other Names:
      • Tecartus™

Eligibility

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

Treatment Sites in Georgia

Northside Hospital Cancer Institute - Bone Marrow Transplant (BMT)


1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-851-8523


**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.