Trial Title:
Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel
NCT ID:
NCT05776134
Condition:
Mantle Cell Lymphoma
Acute Lymphoblastic Leukemia
Conditions: Official terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, Mantle-Cell
Brexucabtagene autoleucel
Study type:
Expanded Access
Overall status:
Available
Intervention:
Intervention type:
Biological
Intervention name:
Brexucabtagene Autoleucel
Description:
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg
administered intravenously.
Other name:
Tecartus™
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
University of Alabama at Birmingham
Address:
City:
Birmingham
Zip:
35234
Country:
United States
Status:
Available
Facility:
Name:
Banner MD Anderson Cancer Center
Address:
City:
Gilbert
Zip:
85234
Country:
United States
Status:
Available
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Available
Facility:
Name:
Colorado Blood Cancer Institute
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Available
Facility:
Name:
Mayo Clinic Jacksonville
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Available
Facility:
Name:
Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Available
Facility:
Name:
Northside Hospital
Address:
City:
Atlanta
Zip:
30342
Country:
United States
Status:
Available
Facility:
Name:
St. Luke's Cancer Institute
Address:
City:
Boise
Zip:
83712
Country:
United States
Status:
Available
Facility:
Name:
Northwestern Memorial Hospital
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Available
Facility:
Name:
The University of Kansas Medical Center
Address:
City:
Westwood
Zip:
66205
Country:
United States
Status:
Available
Facility:
Name:
University of Maryland Cancer Center
Address:
City:
Baltimore
Zip:
21201
Country:
United States
Status:
Available
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Available
Facility:
Name:
Beth Israel Deaconess Medical Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Available
Facility:
Name:
Dana Farber Cancer Institute - Chestnut Hill
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Available
Facility:
Name:
University of Michigan
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Available
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55902
Country:
United States
Status:
Available
Facility:
Name:
Washington University School of Medicine- Siteman Cancer Center
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Available
Facility:
Name:
University of Nebraska Medical Center
Address:
City:
Omaha
Zip:
68198
Country:
United States
Status:
Available
Facility:
Name:
John Theurer Cancer Center at Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Available
Facility:
Name:
Montefiore Medical Center (MMC)
Address:
City:
Bronx
Zip:
10467
Country:
United States
Status:
Available
Facility:
Name:
Roswell Park Cancer Institute
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Status:
Available
Facility:
Name:
Weill Cornell Medicine - NewYork-Presbyterian Hospital
Address:
City:
New York
Zip:
10021
Country:
United States
Status:
Available
Facility:
Name:
Icahn School of Medicine at Mount Sinai
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Available
Facility:
Name:
UNC Hospitals, The University of North Carolina at Chapel Hill
Address:
City:
Chapel Hill
Zip:
27514
Country:
United States
Status:
Available
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Available
Facility:
Name:
The Ohio State University
Address:
City:
Columbus
Zip:
43201
Country:
United States
Status:
Available
Facility:
Name:
Oregon Health & Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Available
Facility:
Name:
Hospital of the University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Available
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Status:
Available
Facility:
Name:
UPMC Hillman Cancer Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Available
Facility:
Name:
Avera Cancer Institute
Address:
City:
Sioux Falls
Zip:
57105
Country:
United States
Status:
Available
Facility:
Name:
Sarah Canon Research Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Available
Facility:
Name:
Vanderbilt-Ingrim Cancer Center
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Available
Facility:
Name:
Baylor University Medical Center
Address:
City:
Dallas
Zip:
75246
Country:
United States
Status:
Available
Facility:
Name:
Houston Methodist Hospital
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Available
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Available
Facility:
Name:
Methodist Healthcare System of San Antonio dba Methodist Hospital
Address:
City:
San Antonio
Zip:
782229
Country:
United States
Status:
Available
Facility:
Name:
Huntsman Cancer Institute, University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Available
Facility:
Name:
Virginia Commonwealth University
Address:
City:
Richmond
Zip:
23298
Country:
United States
Status:
Available
Facility:
Name:
Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Available
Facility:
Name:
West Virginia University
Address:
City:
Morgantown
Zip:
26506
Country:
United States
Status:
Available
Facility:
Name:
Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53227
Country:
United States
Status:
Available
Lead sponsor:
Agency:
Kite, A Gilead Company
Agency class:
Industry
Source:
Gilead Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05776134
https://www.gileadclinicaltrials.com/study/?id=KT-US-472-0141
