The goal of this study is to provide access to brexucabtagene autoleucel for patientsdiagnosed with a disease approved for treatment with brexucabtagene autoleucel, that isotherwise out of specification for commercial release.
Not Provided
Biological: Brexucabtagene Autoleucel
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg
administered intravenously.
Other Name: Tecartus™
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
University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764, United States
Banner MD Anderson Cancer Center
Gilbert 5295903, Arizona 5551752, United States
City of Hope
Duarte 5344147, California 5332921, United States
Colorado Blood Cancer Institute
Denver 5419384, Colorado 5417618, United States
Mayo Clinic Jacksonville
Jacksonville 4160021, Florida 4155751, United States
Winship Cancer Institute
Atlanta 4180439, Georgia 4197000, United States
Northside Hospital
Atlanta 4180439, Georgia 4197000, United States
St. Luke's Cancer Institute
Boise 5586437, Idaho 5596512, United States
Northwestern Memorial Hospital
Chicago 4887398, Illinois 4896861, United States
The University of Kansas Medical Center
Westwood 4281639, Kansas 4273857, United States
University of Maryland Cancer Center
Baltimore 4347778, Maryland 4361885, United States
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926, United States
Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926, United States
Dana Farber Cancer Institute - Chestnut Hill
Boston 4930956, Massachusetts 6254926, United States
University of Michigan
Ann Arbor 4984247, Michigan 5001836, United States
Mayo Clinic
Rochester 5043473, Minnesota 5037779, United States
Washington University School of Medicine- Siteman Cancer Center
St Louis 4407066, Missouri 4398678, United States
University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760, United States
Roswell Park Cancer Institute
Buffalo 5110629, New York 5128638, United States
Weill Cornell Medicine - NewYork-Presbyterian Hospital
New York 5128581, New York 5128638, United States
Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638, United States
University of Rochester Medical Center
Rochester 5134086, New York 5128638, United States
Montefiore Medical Center (MMC)
The Bronx 5110266, New York 5128638, United States
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill 4460162, North Carolina 4482348, United States
Cleveland Clinic
Cleveland 5150529, Ohio 5165418, United States
The Ohio State University
Columbus 4509177, Ohio 5165418, United States
Oregon Health & Science University
Portland 5746545, Oregon 5744337, United States
Hospital of the University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927, United States
Fox Chase Cancer Center
Philadelphia 4560349, Pennsylvania 6254927, United States
UPMC Hillman Cancer Center
Pittsburgh 5206379, Pennsylvania 6254927, United States
Avera Cancer Institute
Sioux Falls 5231851, South Dakota 5769223, United States
Sarah Canon Research Institute
Nashville 4644585, Tennessee 4662168, United States
Tennessee Oncology
Nashville 4644585, Tennessee 4662168, United States
Vanderbilt-Ingrim Cancer Center
Nashville 4644585, Tennessee 4662168, United States
Baylor University Medical Center
Dallas 4684888, Texas 4736286, United States
Houston Methodist Hospital
Houston 4699066, Texas 4736286, United States
MD Anderson Cancer Center
Houston 4699066, Texas 4736286, United States
Methodist Healthcare System of San Antonio dba Methodist Hospital
San Antonio 4726206, Texas 4736286, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City 5780993, Utah 5549030, United States
Virginia Commonwealth University
Richmond 4781708, Virginia 6254928, United States
Fred Hutchinson Cancer Center
Seattle 5809844, Washington 5815135, United States
West Virginia University
Morgantown 4815352, West Virginia 4826850, United States
Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468, United States
Medical Information
844-454-5483(1-844-454-KITE)
medinfo@kitepharma.com
Kite Study Director, Study Director
Kite, A Gilead Company