Engineered t cells take on brain tumors in first human test
NCT ID NCT07569263
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2044
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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UF Health
Gainesville, Florida, 32610, United States
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