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Engineered immune cells target deadly brain tumors in children

NCT ID NCT07680439

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This study tests a new treatment called BCB-276 for children and young adults with diffuse intrinsic pontine glioma (DIPG), a rare and aggressive brain tumor. BCB-276 is made from a patient's own immune cells, which are modified in a lab to recognize and attack the cancer. The treatment is given directly into the fluid around the brain every two weeks for about 7-8 months. The goal is to see if it is safe and can help people live longer.

What this could mean

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

Active substance
BCB-276 (a CAR T cell therapy made from the patient's own immune cells, targeting B7-H3)
What this could lead to
If successful, this could offer a new treatment option for DIPG, a rare and aggressive brain tumor with few effective therapies, potentially improving survival.
What could go wrong
This is an early-phase trial with a small number of participants. The therapy may cause serious side effects, and it is not yet known if it will improve survival compared to standard care.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 75 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jul 2030

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

1 year to 26 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: * Participants must be aged 1 and ≤ 26 years and weigh ≥10kg. * Diagnosis of Diffuse Intrinsic Pontine Glioma (DIPG) based on imaging, with or without biopsy confirmation consistent with high-grade glioma or diffuse midline glioma * Able to tolerate leukapheresis and other study procedures in the opinion of the Investigator. * Central Nervous System (CNS) reservoir catheter present prior to first dose of study drug. * Participant must have completed standard radiation therapy within 6 weeks of enrollment for participation. * Performance Status of ≥ 60; mild to moderate restriction or better. Lansky (under 16 years of age) or Karnofsky (16 years of age or older). * Adequate organ function and overall clinical status to participate, including stable or improving neurologic symptoms. * Participants of childbearing/fathering potential must agree to use highly effective contraception from the time of enrollment through 12 months following the last T cell infusion. * Participants with ventriculoperitoneal (VP) shunts need to have a programable system and be able to tolerate temporary adjustment of the shunt required for study treatment. * Participant must meet all other health and safety criteria defined in the study protocol. * Participant and/or authorized legal representative willing to provide consent/assent for study participation, including participation in the 15-year long term follow up period. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: * Previous tumor-directed therapy or treatment-directed clinical study other than standard radiation with or without temozolamide. * Evidence of metastatic disease. * Requirement of high or increasing doses of corticosteroids prior to participation. * Severe swallowing difficulties or other significant clinical conditions that may interfere with participation. * Presence of an active malignancy other than DIPG. * Active or uncontrolled human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection based on protocol-required laboratory testing. * Pregnant or breastfeeding. * Presence of any condition that, in the Investigator's opinion, would prohibit the participant from undergoing treatment under this protocol.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

    6 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

  • Children's Healthcare of Atlanta

    NOT_YET_RECRUITING

    Atlanta, Georgia, 30329, United States

    Contact Email: •••••@•••••

  • Children's Hospital Los Angeles

    NOT_YET_RECRUITING

    Los Angeles, California, 90027, United States

    Contact Email: •••••@•••••

  • Children's Hospital of Philadelphia

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Lurie Children's Hospital

    NOT_YET_RECRUITING

    Chicago, Illinois, 60611, United States

  • Nationwide Children's Hospital

    NOT_YET_RECRUITING

    Columbus, Ohio, 43205, United States

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

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