Lymphoblastic Leukemia, Acute, AdultNCT06799221
Expanded Access Program for OOS Obe-cel
A study testing Out-of-specification obecabtagene autoleucel in people with Lymphoblastic Leukemia, Acute, Adult and B Cell ALL, run by Autolus Limited at 32 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoblastic Leukemia, Acute, Adult, B Cell ALL
- What is being tested?
- Out-of-specification obecabtagene autoleucel
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 32 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
- Available
Emory
Atlanta, Georgia, 30322
langston
- Available
St. David's South Austin Medical Center
Austin, Texas, 78704
Aravind Ramakrishnan
- Available
University of Maryland Medical Center
Baltimore, Maryland, 21201
Jean Yared
- Available
Massachusetts General Hospital
Boston, Massachusetts, 02114
Matthew Frigault
- Available
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Ilene Galinsky, Ilene_Galinsky@dfci.harvard.edu
Daniel J De Angelo
- Available
Cleveland Clinic
Cleveland, Ohio, 44195
Molina
- Available
The Ohio State University
Columbus, Ohio, 43202
Marcos De Lima
- Available
Medical City Dallas
Dallas, Texas, 75230
Bhushan
- Available
Baylor Scott & White Research Institute
Dallas, Texas, 75246
WyKeisha Riser, tarah.satterfield@keisha.riser@bswhealth.orgbswhealth.org
Houston Holmes
- Available
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Migdady
- Available
City of Hope National Medical Center
Duarte, California, 93534
Dorreth King-Rucker, dkingrucker@coh.org
Karamjeet Sandhu
- Available
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Matthew Ulrickson
- Available
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Michele Donato
- Available
Houston Methodist Hospital
Houston, Texas, 77030
Jane Povey, jspovey@houstonmethodist.org
Shilpin Shah
- Available
MD Anderson Cancer Center
Houston, Texas, 77030
Elias Jabbour
- Available
University of Iowa
Iowa City, Iowa, 52242
Rhonda Evans, rhonda-evans@uiowa.edu
Umar Farooq
- Available
Kansas University Medical Center
Kansas City, Kansas, 66160
Joseph McGuirk
- Available
University of California San Diego Health (UCSD)
La Jolla, California, 92093
Juliana Ongley, jongley@health.ucsd.edu
Dmitrios Tzachanis
- Available
MCW Froedtert
Milwaukee, Wisconsin, 53226
Guru Murthy
- Available
University of Minnesota
Minneapolis, Minnesota, 55455
Veronika Bachanova
- Available
TriStar Centennial Medical Center (SCRI)
Nashville, Tennessee, 37203
Stephanie Larson, stephanie.larson@sarahcannon.com
Battiwalla
- Available
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Oluwole
- Available
NYU-Langone
New York, New York, 10016
Abdul Hay
- Available
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
JaeHong Park
- Available
Orlando Health
Orlando, Florida, 32806
Samer Khaled
- Available
Stanford University
Palo Alto, California, 94304
Lori Muffly
- Available
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Noelle Frey
- Available
City of Hope Phoenix
Phoenix, Arizona, 85338
heather crowe, hcrowe@coh.org
Aileen Go
- Available
Oregon Health and Science University
Portland, Oregon, 97239
Denise Lackey, lackey@ohsu.edu
Hayes-Lattin
- Available
Texas Transplant Institute
San Antonio, Texas, 78229
Cruz
- Available
University of California San Francisco (UCSF)
San Francisco, California, 94143
Aaron Logan
- Available
Washington University School of Medicine
Seattle, Washington, 98195
Hannah Hartman, Hhartman@wustl.edu
Armin Ghobadi
About this study
Official title: 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.
Read more
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.).
- Conditions
- Lymphoblastic Leukemia, Acute, Adult, B Cell ALL
- Being tested
- Out-of-specification obecabtagene autoleucel
- Keywords
- Relapsed B cell acute lymphoblastic leukemia, Refractory B cell acute lymphoblastic leukemia, Adult acute lymphoblastic leukemia, Obecabtagene autoleucel (obe-cel), Obe-cel
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Out-of-specification obecabtagene autoleucelBiological
Also called OOS Obe-cel
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoblastic Leukemia, Acute, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Autolus Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Autolus Study Director, Study director, Autolus Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799221
- Sponsor's protocol ID
- AUTO1-OS1
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Program (EAP) for Obecabtagene Autoleucel (Obe-cel) Out-of-specification (OOS) in Adult Patients With Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT06799221
- Acronym / sponsor ID
- AUTO1-OS1
- Conditions
- Lymphoblastic Leukemia, Acute, Adult, B Cell ALL
- Keywords
- Relapsed B cell acute lymphoblastic leukemia, Refractory B cell acute lymphoblastic leukemia, Adult acute lymphoblastic leukemia, Obecabtagene autoleucel (obe-cel), Obe-cel
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Autolus LimitedIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Out-of-specification obecabtagene autoleucelAlso: OOS Obe-celOut-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. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Autolus Study Director study director
Autolus Limited
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Out-of-specification obecabtagene autoleucel in people with Lymphoblastic Leukemia, Acute, Adult and B Cell ALL, run by Autolus Limited at 32 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Medical Information (855-288-5227, medinfo@autolus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.