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Clinical Trials in China / NCT07641049
Recruiting Phase 1

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

NCT07641049 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Biotech
Phase
Phase 1
Started
2026-03-02
Last updated
2026-06-11

Condition(s) studied

Metastatic Castration-resistant Prostate CancerAdvanced Prostate AdenocarcinomaPSCA-positive Prostate CancerPSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer

Investigational drug(s) / intervention(s)

ETB-DualNK-01FludarabineCyclophosphamide

ETB-DualNK-01: Allogeneic dual-target antiPSMA/PSCA CAR-NK cells administered intravenously on Day 0; repeat infusion permitted only per protocol in Part B.

Fludarabine: Lymphodepletion regimen: 30 mg/m2/day IV on Days -5 to -3 before ETB-DualNK-01 infusion.

Cyclophosphamide: Lymphodepletion regimen: 300 mg/m2/day IV on Days -5 to -3 before ETB-DualNK-01 infusion

Study 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

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University Shenzhen Hospital Shenzhen Guangdong Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07641049 on ClinicalTrials.gov ↗ ← All trials in China