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Engineered immune cells take on deadly brain cancer

NCT ID NCT05353530

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a new therapy made from a patient's own immune cells, modified to better target and attack glioblastoma and other high-grade gliomas. The cells are designed to recognize a protein called CD70 found on these tumors. The main goals are to see if the treatment is safe and possible to deliver in a small group of adults and children.

What this could mean

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

Active substance
8R-70CAR T cells (a type of immune cell modified to target CD70 on tumor cells)
What this could lead to
If successful, this could point toward a new treatment option for glioblastoma and other aggressive brain tumors that are hard to treat.
What could go wrong
This is an early phase 1 trial with only 39 participants, so it is primarily testing safety, not effectiveness. The treatment may cause serious side effects or fail to control the tumor.

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 39 people

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

Started

Jul 2023

Expected to finish

Dec 2042

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 to 80 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 (Adult GBM): * Age ≥ 18 years * Newly-diagnosed de novo GBM based on the absence of previous history of brain tumor (WHO Grade IV glioma) by histopathology or molecular studies. (secondary GBM not eligible) * The tumor must have a supratentorial component * CD70 positive (≥5%, 1+) Tumor expression will be scored on a scale of 0 to 3 staining intensity: 0 = Negative 1. = Low level 2. = Moderate level 3. = High level * The criteria for inclusion will be at least 5% of the cells scoring 1+ staining intensity (\> 5%, 1+). * Surgical resection of tumors with less than 3cm x 3cm (9 cm2) residual enhancing tumor as a product of longest perpendicular planes by MRI or biopsy only for tumor measuring less than 3cm x 3cm * Karnofsky Performance Status (KPS) of \> 70% * CBC with differential with adequate bone marrow function as defined below: * Absolute neutrophil count (ANC) ≥ 1500 cells/mm3. * Platelet count ≥ 100,000 cells/mm3. * Hemoglobin ≥ 10 g/dl. (The use of transfusion or other intervention to achieve Hgb ≥ 10 g/dl is acceptable.) • Adequate renal function as defined below: * BUN ≤ 25 mg/dl * Creatinine ≤ 1.7 mg/dl • Adequate hepatic function as defined below: * Bilirubin ≤ 2.0 mg/dl * ALT ≤ 5 times institutional upper limits of normal for age * AST ≤ 5 times institutional upper limits of normal for age * Signed informed consent. If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the legally authorized representative. * For females of childbearing potential, a negative serum pregnancy test at enrollment. * Women of childbearing potential (WOCBP) must be willing to use an acceptable contraceptive method to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug. * Males with female partners of childbearing potential must agree to practice adequate contraceptive methods throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug. Exclusion Criteria (Adult GBM): * Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3years. (In situ cancer are permissible) * Metastases detected below the tentorium or beyond the cranial vault * Leptomeningeal disease beyond the cranial vault. (Focal, adjacent and leptomeningeal involvement is allowable at the discretion of the PI). * Recurrent or multifocal malignant gliomas. * The patient is not a candidate for cellular therapy as assessed by the study bone marrow transplant physician. * Known immunosuppressive disease or human immunodeficiency virus (HIV) infection. Rationale: The need to exclude patients with the immunosuppressive disease or human * Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization. * Transmural myocardial infarction within the last 6 months. * Acute bacterial or fungal infection requiring intravenous antibiotics at the initiation of XRT/TMZ. * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the initiation of XRT/TMZ. * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects. * Patients with an autoimmune disease requiring medical management with immunosuppressants. * Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy. * Active connective tissue disorders such as lupus or scleroderma that, in the investigator's opinion, place the patient at high risk for radiation toxicity. * Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant. * Patients treated on any other therapeutic clinical protocols within 30 days prior to enrollment.

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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

  • University of Florida Health

    RECRUITING

    Gainesville, Florida, 32608, United States

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