Study Details

PROTOCOL 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.

Participation Requirements

Age

18 Years +

Sex

All

Healthy Volunteers

Medical Condition

Mantle Cell Lymphoma, Acute Lymphoblastic Leukemia

Gender

N/A

Date

Study Type

Expanded Access

Study Phase

Product

Brexucabtagene Autoleucel

Eligibility Information

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

Locations

Locations (26)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

City of Hope

Duarte, California, United States, 91010

Colorado Blood Cancer Institute

Denver, Colorado, United States, 80218

Winship Cancer Institute

Atlanta, Georgia, United States, 30322

Northside Hospital

Atlanta, Georgia, United States, 30342

Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611

The University of Kansas Medical Center

Westwood, Kansas, United States, 66205

University of Maryland Cancer Center

Baltimore, Maryland, United States, 21201

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Dana Farber Cancer Institute - Chestnut Hill

Boston, Massachusetts, United States, 02215

University of Michigan

Ann Arbor, Michigan, United States, 48109

Mayo Clinic

Rochester, Minnesota, United States, 55902

Washington University School of Medicine- Siteman Cancer Center

Saint Louis, Missouri, United States, 63110

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

Montefiore Medical Center

Bronx, New York, United States, 10467

UNC Hospitals, The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27514

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Oregon Health & Science University

Portland, Oregon, United States, 97239

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232

Avera Cancer Institute

Sioux Falls, South Dakota, United States, 57105

Sarah Canon Research Institute

Nashville, Tennessee, United States, 37203

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Methodist Healthcare System of San Antonio dba Methodist Hospital

San Antonio, Texas, United States, 782229

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109

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

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