Immune cells armed with cancer-seeking antibodies tested in advanced cancers
NCT ID NCT07441889
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment for people with metastatic breast or prostate cancer that has stopped responding to standard therapies. Participants receive infusions of their own immune cells that have been armed with a special antibody to help them find and attack cancer cells. The goal is to check the safety of this approach and see if it can shrink tumors or slow the disease.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 23 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2032
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 years and older
- 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: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Age ≥ 18 years at the time of signing informed consent 4. Expected survival ≥ 3 months in the judgment of the investigator 5. ECOG PS 0-1 6. Adequate Organ Function per the following criteria (within 10 days of study registration): * Absolute lymphocyte count ≥ 400/mm3 * Absolute neutrophil count ≥ 1000/mm3 * Platelets ≥ 75,000/mm3 * Hemoglobin ≥ 9g/dL * Serum creatinine \< 2.0 mg/dL OR measured or calculated creatinine clearance ≥ 50 ml/mm * Total bilirubin ≤ mg/dL * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \< 5.0 times normal 7. Agreement to adhere to Lifestyle Considerations throughout study duration 8. A diagnosis of either of the following: a. Prostate Cancer: i. Histological and/or cytological confirmation of prostate adenocarcinoma. ii. Participants must have progressive mCRPC at screening iii. Serum testosterone levels \<50 ng/dL during screening. iv. Must have progressed on at least one prior ARPI (abiraterone acetate, enzalutamide, apalutamide, or darolutamide). v. Participants must have ≥1 metastatic lesion that is present on baseline CT, MRI, or bone scan obtained ≤28 days prior to registration. b. Breast Cancer i. Histological and/or cytological confirmation of invasive breast cancer. ii. Participants must have previously treated metastatic breast cancer at screening. Metastatic breast cancer must be evaluable by RECIST 1.1 criteria. iii. Must have progressed on at least two prior endocrine or targeted therapies or at least two lines of cytotoxic chemotherapy. If HER2 positive, then must have progressed on or been intolerant of at least one HER2 targeted therapy. iv. Participants must have ≥1 metastatic lesion that is present on baseline CT, MRI, or bone scan obtained ≤28 days prior to registration. Exclusion Criteria: 1. Pregnancy (must have negative pregnancy test within 7 days prior to study registration) or lactation 2. History of a recent myocardial infarction (within one year) or a past myocardial infarction (more than one year prior to enrollment) who are actively requiring nitroglycerine more than once per week 3. Inadequate cardiac function, as defined as any of the following: * Uncontrolled angina or severe ventricular arrhythmias * Clinically significant pericardial disease * History of myocardial infarction (MI) in the last year before registration * Class 3 or higher New York Heart Association Congestive Heart Failure 4. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 5. Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration 6. Active liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis 7. Is HIV positive or has evidence of active Hepatitis C virus or active Hepatitis B virus. 8. Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed) 9. Has an active infection requiring systemic therapy 10. A serious uncontrolled medical disorder that in the opinion of the Investigator may be jeopardized by the treatment with protocol therapy 11. Has a known history of active TB (Bacillus Tuberculosis) 12. Has received a live vaccine within 30 days of study registration. 13. Treatment with any investigational agent within 3 weeks prior to study registration 14. Active second malignancy requiring systemic treatment. Exceptions include basal cell carcinoma of the skin, treated cervical cancer, and squamous cell carcinoma of the skin 15. Has active autoimmune disease that has required systemic treatment in the 2 years prior to registration (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 16. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. 17. Patient may be excluded if, in the opinion of the PI and investigator team, the patient is not capable of being compliant Additional Exclusion Criteria for Patients with Prostate Cancer: 1. Has small cell neuroendocrine carcinoma (pure or mixed) on prior or current histologic evaluation of primary or metastatic lesions 2. Has an actionable BRCA1 or BRCA2 alteration, for which approved therapies are available, e.g., PARP inhibitors, unless these therapies are not appropriate for the participant as determined by the investigator or the participant refuses such therapy. Participants with one of these mutations and who have progressed on targeted therapy are eligible. Additional Exclusion Criteria for Patients with Breast Cancer: 1. Has an actionable BRCA1 or BRCA2 alteration, for which approved therapies are available, e.g., PARP inhibitors, unless these therapies are not appropriate for the participant as determined by the investigator or the participant refuses such therapy. Participants with one of these mutations and who have progressed on targeted therapy are eligible. 2. Participants in visceral crisis at risk of immediately life-threatening complications in the short term, including participants with massive uncontrolled effusions (pleural, pericardial, and peritoneal), pulmonary lymphangitis, or liver involvement \> 50%.
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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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University of Virginia
RECRUITINGCharlottesville, Virginia, 22903, United States
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