Dual-target PSMA/PSCA CAR-NK Therapy in Advanced Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 study evaluates the safety, tolerability, feasibility, and preliminary anti-tumor activity of ETB-DualNK-01 in adults with metastatic castration-resistant prostate cancer. Part A uses dose escalation to identify the maximum tolerated dose or recommended Phase 2 dose, while Part B expands at the selected dose in patients with biomarker-confirmed disease. The therapy targets both PSMA and PSCA to improve tumor coverage and mitigate antigen escape, with lymphodepletion followed by infusion of allogeneic CAR-NK cells. Participants require PSMA and/or PSCA expression, ongoing androgen deprivation, and measurable disease, with regular imaging and PSA monitoring.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University Shenzhen Hospital
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Study coordinator: Seni S Lu, Phd
• Email: Seni-Lu@beijing-biotech.com
• Phone: +86 13076790030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.