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
Beijing Biotech
36 participants
Mar 2, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria10
- 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 Criteria9
- 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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Interventions
Allogeneic dual-target antiPSMA/PSCA CAR-NK cells administered intravenously on Day 0; repeat infusion permitted only per protocol in Part B.
Lymphodepletion regimen: 30 mg/m2/day IV on Days -5 to -3 before ETB-DualNK-01 infusion.
Lymphodepletion regimen: 300 mg/m2/day IV on Days -5 to -3 before ETB-DualNK-01 infusion
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07641049