Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Last-Resort leukemia treatment made available through expanded access program

NCT ID NCT06799221

Disease control Sponsor: Autolus Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access This study
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This expanded access program provides an experimental CAR-T cell therapy called obe-cel to adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) who have no other treatment options. The therapy is made from the patient's own blood cells but did not meet commercial quality standards. The program aims to offer a potential lifeline while monitoring safety and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
obecabtagene autoleucel (obe-cel), a CAR-T cell therapy made from the patient's own immune cells
What this could lead to
If this program works, it could offer a treatment option for people with hard-to-treat leukemia who have run out of standard choices.
What could go wrong
This is an early access program, not a formal trial, so results are uncertain. The product is out-of-specification, meaning it may be less effective or carry unknown risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for B cell ALL are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

adult acute lymphoblastic leukemia B-cell acute lymphoblastic leukemia Burkitt lymphoma Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

B cell ALL Lymphoblastic leukemia, acute, adult

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    32 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Banner MD Anderson Cancer Center

    AVAILABLE

    Gilbert, Arizona, 85234, United States

  • Baylor Scott & White Research Institute

    AVAILABLE

    Dallas, Texas, 75246, United States

  • City of Hope National Medical Center

    AVAILABLE

    Duarte, California, 93534, United States

  • City of Hope Phoenix

    AVAILABLE

    Phoenix, Arizona, 85338, United States

  • Cleveland Clinic

    AVAILABLE

    Cleveland, Ohio, 44195, United States

  • Colorado Blood Cancer Institute

    AVAILABLE

    Denver, Colorado, 80218, United States

  • Dana-Farber Cancer Institute

    AVAILABLE

    Boston, Massachusetts, 02115, United States

  • Emory

    AVAILABLE

    Atlanta, Georgia, 30322, United States

  • Hackensack University Medical Center

    AVAILABLE

    Hackensack, New Jersey, 07601, United States

  • Houston Methodist Hospital

    AVAILABLE

    Houston, Texas, 77030, United States

  • Kansas University Medical Center

    AVAILABLE

    Kansas City, Kansas, 66160, United States

  • MCW Froedtert

    AVAILABLE

    Milwaukee, Wisconsin, 53226, United States

  • MD Anderson Cancer Center

    AVAILABLE

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    AVAILABLE

    Boston, Massachusetts, 02114, United States

  • Medical City Dallas

    AVAILABLE

    Dallas, Texas, 75230, United States

  • Memorial Sloan Kettering Cancer Center

    AVAILABLE

    New York, New York, 10065, United States

  • NYU-Langone

    AVAILABLE

    New York, New York, 10016, United States

  • Oregon Health and Science University

    AVAILABLE

    Portland, Oregon, 97239, United States

  • Orlando Health

    AVAILABLE

    Orlando, Florida, 32806, United States

  • St. David's South Austin Medical Center

    AVAILABLE

    Austin, Texas, 78704, United States

  • Stanford University

    AVAILABLE

    Palo Alto, California, 94304, United States

  • Texas Transplant Institute

    AVAILABLE

    San Antonio, Texas, 78229, United States

  • The Ohio State University

    AVAILABLE

    Columbus, Ohio, 43202, United States

  • TriStar Centennial Medical Center (SCRI)

    AVAILABLE

    Nashville, Tennessee, 37203, United States

  • University of California San Diego Health (UCSD)

    AVAILABLE

    La Jolla, California, 92093, United States

  • University of California San Francisco (UCSF)

    AVAILABLE

    San Francisco, California, 94143, United States

  • University of Iowa

    AVAILABLE

    Iowa City, Iowa, 52242, United States

  • University of Maryland Medical Center

    AVAILABLE

    Baltimore, Maryland, 21201, United States

  • University of Minnesota

    AVAILABLE

    Minneapolis, Minnesota, 55455, United States

  • University of Pennsylvania

    AVAILABLE

    Philadelphia, Pennsylvania, 19104, United States

  • Vanderbilt University Medical Center

    AVAILABLE

    Nashville, Tennessee, 37232, United States

  • Washington University School of Medicine

    AVAILABLE

    Seattle, Washington, 98195, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.