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Engineered immune cells target deadly brain tumors in new trial

NCT ID NCT07544992

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This early-phase trial tests the safety of a new treatment for people with recurrent or progressive high-grade glioma, a serious brain cancer. The therapy uses the patient's own immune cells, modified in a lab to recognize and attack tumor cells, and delivers them directly into the brain. The study aims to find the best dose and monitor side effects in 24 adults.

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 24 people

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

Started

May 2026

Expected to finish

Nov 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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.

Main Inclusion Criteria * Documented informed consent of the participant and/or legally authorized representative. * Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with Study PI approval. * Age 18 years and older. * KPS ≥ 70%, ECOG ≤ 2 (Appendix A). * Life expectancy ≥ 4 weeks. * Participant has a prior histologically confirmed diagnosis of a glioblastoma (IDH-wildtype) or grade 4 IDH-mutant astrocytoma, or has a prior histologically confirmed diagnosis of a grade 2 or 3 astrocytoma and now has radiographic progression consistent with grade 4 IDH-mutant astrocytoma. * Relapsed disease: radiographic evidence of recurrence/progression of measurable disease after standard therapy (such as temozolomide with or without Optune device), and ≥ 12 weeks after completion of front-line radiation therapy. * COH Clinical Pathology assessment at the initial tumor presentation or recurrent disease (reference Appendix B): * IL13Rα2+ expression by IHC \> 20, and * EGFR gene-altered by NGS or FISH analysis * No known contraindications to leukapheresis, steroids, imaging studies, or tocilizumab. * WBC \> 2000 /dl (or ANC ≥ 1,000/mm3) * Platelets ≥ 75,000/mm3 * Hemoglobin \> 9g/dL * Total bilirubin ≤ 1.5x ULN * AST ≤ 2.5x ULN * ALT ≤ 2.5x ULN * Serum creatinine ≤1.6 mg/dL * O2 saturation ≥ 95% on room air. * Seronegative for HIV Ag/Ab combo, HCV, and active HBV * Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. * Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of CAR T cells. Main Exclusion Criteria * Owing to higher frequency of wound-related complications, participants who require active bevacizumab therapy at the time of enrollment are excluded. * Participant has not yet recovered from toxicities of prior therapy. * Participant has received any live vaccine within 30 days prior to enrollment. * Uncontrolled seizure activity and/or clinically evident progressive encephalopathy. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent. * Clinically significant uncontrolled illness. * Active autoimmune disease requiring systemic immunosuppressive therapy * Active infection requiring IV antibiotics (for example, minor scalp infection is not exclusion). * Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection. * Other active malignancy. * Females only: Pregnant or breastfeeding. * Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures. * Prospective participants who, in the opinion of the Investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).

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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 places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • City of Hope Medical Center

    RECRUITING

    Duarte, California, 91010, United States

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