Engineered t cells take on brain tumors in first human test

NCT ID NCT07569263

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 09, 2026 · Updated 2 times

Summary

This early-phase trial tests a new type of immunotherapy for adults with brain metastases from various cancers. The treatment uses the patient's own immune cells, modified to better target and attack tumor cells. The main goals are to see if the approach is safe and feasible in 12 participants.

What this could mean

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

Active substance
IL-8 receptor modified CD70 CAR T cells
What this could lead to
If successful, this could point toward a new treatment option for brain metastases that are hard to treat with standard therapies.
What could go wrong
This is a very early Phase I trial with only 12 participants, focused on safety. It may not show benefit, and there are risks of serious side effects from the cell therapy.

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 12 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2044

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: * Histological confirmation of primary cancers * Histologic confirmation of CD70 on primary tumor, lymph node, or BM biopsy * At least one recurrent or progressive metastatic lesion or new metastatic lesion(s). * KPS ≥ 70. * 18 years or older. * Adequate bone marrow and organ function as defined below: * CBC with differential with adequate bone marrow function as defined below: * Absolute neutrophil count (ANC) ≥ 10000 cells/mm3. * Platelet count ≥ 75,000 cells/mm3. * Hemoglobin ≥ 9 g/dl. (use of transfusion or other intervention to achieve Hgb ≥ 9 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 * A diagnostic contrast-enhanced brain MRI must be performed within 28 days prior to study enrollment. * 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 the study drug. * Ability of the patient to understand and willingness to sign an IRB approved written informed consent document. * Steroid dose equivalent to dexamethasone dose of ≤ 6mg daily at the time of enrollment. * Patients treated on any other investigational therapy must discontinue that treatment prior to study entry. Exclusion Criteria: • Known immunosuppressive disease or human immunodeficiency virus (HIV) infection. Rationale: The need to exclude patients with an immunosuppressive disease or human immunodeficiency virus infection is necessary because the management of potential toxicities from the study drug may involve treatment that is significantly immunosuppressive. * Participant has ongoing toxicity ≥ grade 2 per the CTCAE version 5.0 considered clinically significant and in the opinion of the investigator, attributable to prior antineoplastic therapies. * Participant has received any chemotherapy or other immunotherapy within 14 days prior to the first dose of study intervention. * 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. * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization. * 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. * Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant.

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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

  • UF Health

    Gainesville, Florida, 32610, United States

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