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

Status

Indicates the current recruitment status or the expanded access status.
Available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Expanded Access Type

Expanded Access Type

Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
  • Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
  • Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
  • Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Autolus Limited

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
IQVIA Pty Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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