Expanded Access Program for OOS Obe-cel

February 25, 2026 updated by: Autolus Limited

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

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 Overview

Status

Available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient (or legally authorized representative) is willing to provide informed consent.
  • Patient must be 18 years of age or older.
  • Patient must have a confirmed diagnosis of relapsed/refractory B cell ALL.
  • Commercial obe-cel was indicated to the patient by their treating physician as per standard of care prior to leukapheresis.
  • The final manufactured obe-cel does not meet the commercial release specifications.
  • The final manufactured obe-cel is acceptable per joint assessment by Autolus and physician taking into account Autolus' release criteria.
  • Remanufacturing (i.e., repeat leukapheresis and manufacturing) is not clinically appropriate per the treating physician's assessment.
  • Patient deemed medically fit and stable to receive obe-cel infusions per their treating physician's evaluation.
  • For females of childbearing potential (defined as < 24 months after last menstruation or not surgically sterile), a negative serum or urine pregnancy test must be documented at screening, prior to lymphodepletion therapy and confirmed before receiving the first dose of study treatment.
  • For females who are not postmenopausal (< 24 months of amenorrhea) or who are not surgically sterile (absence of ovaries and/or uterus), 2 methods of contraception comprising 1 highly effective method of contraception together with a barrier method must be used during the treatment period and for at least 12 months after the last dose of study treatment. They must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 12 months after receiving the last dose of study drug.
  • For males, it must be agreed that 2 acceptable methods of contraception are used (1 by the patient - usually a barrier method, and 1 highly effective method by the patient's partner) during the treatment period and for at least 12 months after the last dose of study treatment and that sperm will not be donated during the treatment period and for at least 12 months after the last dose of study treatment.

Exclusion Criteria:

  • History of severe immediate hypersensitivity to any drugs or metabolites of similar chemical classes as obe-cel.
  • Pregnant women.
  • Active participation in an interventional trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Autolus Limited

Collaborators

IQVIA Pty Ltd

Investigators

  • Study Director: Autolus Study Director, Autolus Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 23, 2025

First Submitted That Met QC Criteria

January 23, 2025

First Posted (Actual)

January 29, 2025

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUTO1-OS1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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