Engineered immune cells take aim at Hard-to-Treat prostate cancer
NCT ID NCT07641049
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new treatment called ETB-DualNK-01 for men with advanced prostate cancer that has stopped responding to hormone therapy. The treatment uses donor immune cells (NK cells) that are engineered to target two cancer markers, PSMA and PSCA. The study aims to find a safe dose and see if the cells 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
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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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Male participants only
- 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: * Male participant age 18 years or older. * Histologically or cytologically confirmed prostate adenocarcinoma with metastatic castration-resistant disease. * Disease progression by PCWG3 while maintaining castrate testosterone (\<50 ng/dL) with ongoing androgen deprivation therapy or prior orchiectomy. * Documented PSMA and/or PSCA expression by a validated tumor assay; PSMA PET may support target confirmation when applicable. * Prior progression on at least one androgen receptor pathway inhibitor such as abiraterone, enzalutamide, apalutamide, or darolutamide; prior taxane, PARP inhibitor, radioligand therapy, or checkpoint inhibitor is allowed. * ECOG performance status 0 or 1. * Adequate hematologic, renal, hepatic, cardiac, and pulmonary function per protocol laboratory thresholds. * At least one measurable lesion by RECIST 1.1 or evaluable bone-predominant disease by PCWG3. * Life expectancy of at least 12 weeks. * Ability to understand and sign informed consent and willingness to provide required blood and tissue samples. Exclusion Criteria: * Active central nervous system metastases or leptomeningeal disease. * Dominant small-cell or neuroendocrine prostate cancer histology. * Prior gene-modified cellular therapy within 6 months before lymphodepletion, or prior allogeneic transplant requiring ongoing systemic immunosuppression. * Active autoimmune disease requiring systemic treatment or chronic immunosuppression; systemic corticosteroid use greater than 10 mg prednisone equivalent daily within 7 days of lymphodepletion. * Uncontrolled infection, including uncontrolled hepatitis B, hepatitis C, or HIV infection. * Clinically significant cardiovascular disease, symptomatic arrhythmia, recent myocardial infarction, or uncontrolled heart failure. * Unresolved grade 2 or higher toxicity from prior anticancer therapy, except alopecia, stable endocrinopathy, or other protocol-approved exceptions. * Another active malignancy requiring systemic treatment. * Any medical, psychiatric, or laboratory abnormality that, in the investigator's judgment, would increase risk or interfere with study interpretation.
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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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Peking University Shenzhen Hospital
RECRUITINGShenzhen, Guangdong, 518036, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Training a Patient's own immune cells to fight advanced prostate cancer
- Radioactive missile aims at prostate cancer that spread
- First-in-Human biologic JUR-003 put to the test against metastatic prostate cancer
- New drug combo targets CD46 in aggressive prostate cancer
- Can a Hormone-Blocking drug boost chemotherapy against prostate cancer?
- Can a Cancer-Targeting drug slow advanced prostate cancer?