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Engineered immune cells take on childhood blood cancers in early trial

NCT ID NCT06173518

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 study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 17, 2026 · Updated 3 times

Summary

This early-phase trial is testing a new CAR T-cell therapy called AUTO1 (obe-cel) in up to 30 children with B-cell acute lymphoblastic leukemia or B-cell non-Hodgkin lymphoma that has returned or not responded to treatment. The therapy uses the child's own immune cells, which are modified in a lab to recognize and attack cancer cells. The main goals are to check safety and see how many children achieve complete remission within three months.

What this could mean

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

Active substance
AUTO1 (Obecabtagene autoleucel [Obe-cel]) - a type of CAR T-cell therapy made from the patient's own immune cells
What this could lead to
If successful, this could offer a new treatment option for children with hard-to-treat B-cell cancers that have come back or not responded to standard therapy.
What could go wrong
This is an early-phase trial with only 30 participants, so results may not apply to all patients. CAR T-cell therapy can cause serious side effects like cytokine release syndrome and low antibody levels.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Nov 2027

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

0 to 18 years

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: * \< 18 years old at screening * ≥ 6 kg body weight at screening Pediatric patients with r/r B ALL r/r CD19-positive aggressive mature B including the B NHL subtypes: i) diffuse large B cell lymphoma, ii) Burkitt's lymphoma, iii) primary mediastinal large B cell lymphoma, iv) high-grade B cell lymphoma (not otherwise specified). * Karnofsky (age ≥ 10 years) or Lansky (age \< 10 year) performance status score ≥ 50%. * In participants with B ALL, local documentation of CD19 expression on leukemic blasts in the BM, peripheral blood, or cerebrospinal fluid or biopsy done no more than 30 days prior to consent. * Adequate renal, hepatic, pulmonary, and cardiac function. EXCLUSION CRITERIA: * Diagnosis of chronic myelogenous leukemia in lymphoid blast crisis. * History or presence of clinically relevant central nervous system (CNS) pathology unrelated to CNS leukemia. * Presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management. * Received prior (\< 3 months before obe cel infusion) stem cell transplantation. * Prior CD19 targeted therapy other than blinatumomab. * Experienced Grade ≥ 3 neurotoxicity following blinatumomab.

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Conditions

The condition(s) this trial relates to.

B-cell acute lymphoblastic leukemia B-cell neoplasm B-cell non-Hodgkin lymphoma Burkitt lymphoma Precursor Cell Lymphoblastic Leukemia-Lymphoma Recurrence relapsed/refractory diffuse large B-cell lymphoma

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 Relapsed or refractory B cell non-Hodgkin lymphoma

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

    9 sites in 3 countries. 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

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Great North Children's Hospital

    RECRUITING

    Newcastle upon Tyne, United Kingdom

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    RECRUITING

    London, United Kingdom

  • Hospital Nino Jesus

    RECRUITING

    Madrid, Spain

  • Hospital Vall d'Hebron

    RECRUITING

    Barcelona, Spain

  • Methodist Children's Hospital

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Primary Children's Hospital

    RECRUITING

    Salt Lake City, Utah, 84113, United States

  • Royal Manchester Children's Hospital

    RECRUITING

    Manchester, United Kingdom

  • The Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

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