Expanded Access Program for OOS Obe-cel

ClinicalTrials.gov ID: NCT06799221

Public ClinicalTrials.gov record NCT06799221. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 6, 2026, 1:22 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Expanded Access Program (EAP) for Obecabtagene Autoleucel (Obe-cel) Out-of-specification (OOS) in Adult Patients With Acute Lymphoblastic Leukemia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The 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.).

Study identification

NCT ID: NCT06799221
Recruitment status: Available
Study type: Expanded access
Phase: Not listed
Lead sponsor: Autolus Limited; Industry
Enrollment: Not listed

Conditions and interventions

Conditions

Interventions

Out-of-specification obecabtagene autoleucel Biological

Biological

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Not listed
Primary completion: Not listed
Completion: Not listed
Last update posted: Feb 26, 2026

United States locations

U.S. sites: 32
U.S. states: 19
U.S. cities: 27

Facility	City	State	ZIP	Site status
Banner MD Anderson Cancer Center	Gilbert	Arizona	85234	Available
City of Hope Phoenix	Phoenix	Arizona	85338	Available
City of Hope National Medical Center	Duarte	California	93534	Available
University of California San Diego Health (UCSD)	La Jolla	California	92093	Available
Stanford University	Palo Alto	California	94304	Available
University of California San Francisco (UCSF)	San Francisco	California	94143	Available
Colorado Blood Cancer Institute	Denver	Colorado	80218	Available
Orlando Health	Orlando	Florida	32806	Available
Emory	Atlanta	Georgia	30322	Available
University of Iowa	Iowa City	Iowa	52242	Available
Kansas University Medical Center	Kansas City	Kansas	66160	Available
University of Maryland Medical Center	Baltimore	Maryland	21201	Available
Massachusetts General Hospital	Boston	Massachusetts	02114	Available
Dana-Farber Cancer Institute	Boston	Massachusetts	02115	Available
University of Minnesota	Minneapolis	Minnesota	55455	Available
Hackensack University Medical Center	Hackensack	New Jersey	07601	Available
NYU-Langone	New York	New York	10016	Available
Memorial Sloan Kettering Cancer Center	New York	New York	10065	Available
Cleveland Clinic	Cleveland	Ohio	44195	Available
The Ohio State University	Columbus	Ohio	43202	Available
Oregon Health and Science University	Portland	Oregon	97239	Available
University of Pennsylvania	Philadelphia	Pennsylvania	19104	Available
TriStar Centennial Medical Center (SCRI)	Nashville	Tennessee	37203	Available
Vanderbilt University Medical Center	Nashville	Tennessee	37232	Available
St. David's South Austin Medical Center	Austin	Texas	78704	Available
Medical City Dallas	Dallas	Texas	75230	Available
Baylor Scott & White Research Institute	Dallas	Texas	75246	Available
Houston Methodist Hospital	Houston	Texas	77030	Available
MD Anderson Cancer Center	Houston	Texas	77030	Available
Texas Transplant Institute	San Antonio	Texas	78229	Available
Washington University School of Medicine	Seattle	Washington	98195	Available
MCW Froedtert	Milwaukee	Wisconsin	53226	Available

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06799221, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Feb 26, 2026 · Synced Sep 6, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06799221 live on ClinicalTrials.gov.

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