NCT07641049RecruitingPhase 1
Dual-target PSMA/PSCA CAR-NK Cells in Advanced Prostate Cancer
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
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 6 Jun 2026
- Start date
- 2 Mar 2026
- Primary completion date
- 14 Mar 2027
- Lead sponsor
- Beijing Biotech
- Diseases
- Prostate cancer
- NCT number
- NCT07641049
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 36
- From 2 Mar 2026 to the primary completion date, 14 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- Any medical, psychiatric, or laboratory abnormality that, in the investigator's judgment, would increase risk or interfere with study interpretation.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Shenzhen Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.