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Engineered immune cells take on tough leukemia in new trial

NCT ID NCT04404660

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a treatment called AUTO1, a type of CAR T cell therapy, in 153 adults whose B cell acute lymphoblastic leukemia has returned or not responded to standard treatments. The therapy involves taking a patient's own immune cells, engineering them to recognize and attack cancer cells, and giving them back after chemotherapy. The goal is to see if it is safe and effective at controlling the leukemia.

What this could mean

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

Active substance
AUTO1 (also called obecabtagene autoleucel or obe-cel), a CAR T cell therapy that targets CD19 on cancer cells
What this could lead to
If successful, this could offer a new treatment option for adults with hard-to-treat B cell acute lymphoblastic leukemia, potentially leading to long-term disease control.
What could go wrong
This is an early-phase (1b/2) trial, so the therapy may not work for everyone. Side effects can be serious, including cytokine release syndrome and neurological issues.

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.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

153 people

The number who actually took part.

Started

Jun 2020

Expected to finish

Jun 2029

An estimate. End dates often move.

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

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Age 18 years or older * ECOG performance status of 0 or 1 * Relapsed or refractory B cell ALL * Patients with Ph+ ALL are eligible if intolerant to TKI, failed two lines of any TKI, or failed one line of second-generation TKI, or if TKI is contraindicated * Documented CD19 positivity within 1 month of screening * Phase 1b: Primary Cohort IA: Presence of ≥5% blasts in BM at screening * Phase 1b: Exploratory Cohort IB: MRD-positive defined as ≥ 1e-4 and \<5% blasts in the BM at screening * Phase 2: Primary Cohort IIA: Presence of ≥5% blasts in BM at screening * Phase 2: Cohort IIB: ≥2nd CR or CRi with MRD-positive defined as ≥1e-3 by central NGS testing and \<5% blasts in the BM at screening * Adequate renal, hepatic, pulmonary, and cardiac function Exclusion Criteria: * Phase 1b (Cohort IA and Cohort IB) and Phase 2 (Cohort IIA and Cohort IIB) B-ALL with isolated EM disease * Diagnosis of Burkitt's leukaemia/lymphoma or CML lymphoid in blast crisis * History or presence of clinically relevant CNS pathology * Presence of CNS-3 disease or CNS-2 disease with neurological changes * Presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management * Active or latent Hepatitis B virus or active Hepatitis C virus * Human Immunodeficiency Virus (HIV), HTLV-1, HTLV-2, syphilis positive test * Prior CD19 targeted therapy other than blinatumomab. Patients who have experienced Grade 3 or higher neurotoxicity following blinatumomab.

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Conditions

The condition(s) this trial relates to.

B-cell acute lymphoblastic leukemia Burkitt lymphoma Recurrence

As listed by the trial registrant

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

Relapsed or refractory B-cell acute lymphoblastic leukemia

Contacts and locations

Locations

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75246, United States

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

  • City of Hope National Medical Center

    Duarte, California, 93534, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Colorado Blood Cancer Institute (CBCI)

    Denver, Colorado, 80218, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

  • Fundacio' Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • H Lee Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Hospital Universitario La Fé

    Valencia, 46026, Spain

  • Hospital Universitario Virgen del Rocío

    Seville, 41013, Spain

  • King's College Hospital

    London, Greater London, SE5 9RS, United Kingdom

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Manchester Royal Infirmary Hospital

    Manchester, Greater Manchester, M13 9WL, United Kingdom

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Queen Elizabeth University Hospital

    Glasgow, Scotland, G514TF, United Kingdom

  • TTI-Methodist (Texas Transplant Institute) (SCRI)

    San Antonio, Texas, 78229, United States

  • The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • TriStar Centennial Medical Center (SCRI)

    Nashville, Tennessee, 37203, United States

  • University College London Hospitals NHS Foundation Trust

    London, Greater London, NW1 2PG, United Kingdom

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, West Midlands, B15 2GW, United Kingdom

  • University Hospitals Bristol and Weston NHS Foundation Trust (UHBW)

    Bristol, BS2 8ED, United Kingdom

  • University of California Davis (UC Davis)

    Sacramento, California, 95817, United States

  • University of California San Diego Health (UCSD)

    La Jolla, California, 92093, United States

  • University of California San Francisco (UCSF)

    San Francisco, California, 94143, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Kansas

    Kansas City, Kansas, 66160, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Nebraska

    Omaha, Nebraska, 68105, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322, United States

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