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Expanded Access Program (EAP) for Obecabtagene Autoleucel (Obe-cel) Out-of-specification (OOS) in Adult Patients With Acute Lymphoblastic Leukemia
Sponsor study identifier
expanded_access
N/A
1 country
32
Study Start
Not reported
Date not reportedPrimary Completion
Not reported
Date not reportedStudy Completion
Not reported
Date not reportedThe purpose of this program is to provide access to obe-cel treatment for adult patients with ALL who have undergone leukapheresis and had obe-cel manufactured from their blood cells but the product is deemed OOS (does not meet the specifications to be used commercially). The target patients for this study have limited options for treatment and repeat blood sampling is not feasible. The main aims of this study are (1) to provide adult patients with ALL with access to obe-cel and (2) to describe the safety profile of obe-cel (including CRS, ICANS, serious infections, secondary cancers, and any side effects) within the first 45 days after infusion of OOS obe-cel. This study is a single-arm, open-label, multicenter expanded access program (EAP). The patient population included in this EAP will be adult patients diagnosed with recurring or refractory ALL who were prescribed obe-cel as part of their standard of care and are eligible for use under the approved local prescribing information. To be in the study, patients must provide informed consent, be at least 18 years of age, have a confirmed diagnosis of ALL, be medically fit and stable to receive obe-cel, have had commercial obe-cel prescribed by their treating physician as per standard of care, and for whom remanufacturing is not clinically appropriate. Patients cannot be in the study if they have a history of severe immediate allergic reaction to any drugs or metabolites of similar chemical classes as obe-cel, are a pregnant woman, or are receiving treatment in another study. All data will be collected from information routinely recorded in the medical record. There is no formal hypothesis testing. Data will be analyzed descriptively (numbers, percentages and ranges, etc.).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 23, 2025
Actual (reported)January 29, 2025
Actual (reported)Out-of-specification (OOS) obecabtagene autoleucel (obe-cel) given as a split-dose infusion based on tumor burden assessment at lymphodepletion according to the United States prescribing information.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
City of Hope Phoenix
Phoenix, Arizona, 85338, United States
City of Hope National Medical Center
Autolus Study Director
Autolus Limited
First Submitted
January 23, 2025
First Posted
January 29, 2025
Last Updated
February 27, 2026
Record last verified: 2026-02
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Source: ClinicalTrials.gov.
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Duarte, California, 93534, United States
University of California San Diego Health (UCSD)
La Jolla, California, 92093, United States
Stanford University
Palo Alto, California, 94304, United States
University of California San Francisco (UCSF)
San Francisco, California, 94143, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Orlando Health
Orlando, Florida, 32806, United States
Emory
Atlanta, Georgia, 30322, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Kansas University Medical Center
Kansas City, Kansas, 66160, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
NYU-Langone
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University
Columbus, Ohio, 43202, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
TriStar Centennial Medical Center (SCRI)
Nashville, Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
St. David's South Austin Medical Center
Austin, Texas, 78704, United States
Medical City Dallas
Dallas, Texas, 75230, United States
Baylor Scott & White Research Institute
Dallas, Texas, 75246, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Transplant Institute
San Antonio, Texas, 78229, United States
Washington University School of Medicine
Seattle, Washington, 98195, United States
MCW Froedtert
Milwaukee, Wisconsin, 53226, United States