Testing a donor immune cell therapy in men with advanced prostate cancer
Tests ETB-DualNK-01 immune cells in adults with spreading, treatment-resistant prostate cancer.
Plain-language title generated from the registry record
Registry title: Dual-target PSMA/PSCA CAR-NK Cells in Advanced Prostate Cancer
Key facts
- Where
- Shenzhen, ChinaSee the site
- Phase
- Phase 1
Where in China
- Peking University Shenzhen HospitalShenzhen, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing Biotech
- Trial code
- NCT07641049
- Record updated
- 11 June 2026
- Original description
This example Phase 1 study is designed to evaluate the safety, tolerability, feasibility, and preliminary anti-tumor activity of ETB-DualNK-01, an allogeneic dual-target PSMA/PSCA CAR-NK cell therapy, in adults with metastatic castration-resistant prostate cancer (mCRPC). Part A uses dose escalation to determine the maximum tolerated dose and/or recommended Phase 2 dose. Part B expands at the selected dose in biomarkerconfirmed disease.Read full original descriptionShow less
A Phase 1, Open-Label, Multicenter, Dose-Escalation and Dose-Expansion Study of ETB-DualNK-01, an Allogeneic Dual-target PSMA/PSCA CAR-NK Cell Product, in Adults With Metastatic Castration-Resistant Prostate Cancer
This example Phase 1 study is designed to evaluate the safety, tolerability, feasibility, and preliminary anti-tumor activity of ETB-DualNK-01, an allogeneic dual-target PSMA/PSCA CAR-NK cell therapy, in adults with metastatic castration-resistant prostate cancer (mCRPC). Part A uses dose escalation to determine the maximum tolerated dose and/or recommended Phase 2 dose. Part B expands at the selected dose in biomarkerconfirmed disease.
Inclusion: 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: Prior gene-modified cellular therapy within 6 months before lymphodepletion, or prior allogeneic transplant requiring ongoing systemic immunosuppression; Unresolved grade 2 or higher toxicity from prior anticancer therapy, except alopecia, stable endocrinopathy, or other protocol-approved exceptions; Active central nervous system metastases or leptomeningeal disease; Dominant small-cell or neuroendocrine prostate cancer histology; 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; 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.