Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel
- Conditions
- Mantle Cell LymphomaAcute Lymphoblastic Leukemia
- Registration Number
- NCT05776134
- Lead Sponsor
- Kite, A Gilead Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (44)
Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
City of Hope
🇺🇸Duarte, California, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Northside Hospital
🇺🇸Atlanta, Georgia, United States
St. Luke's Cancer Institute
🇺🇸Boise, Idaho, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Scroll for more (34 remaining)Tennessee Oncology🇺🇸Nashville, Tennessee, United States