Dual-target PSMA/PSCA CAR-NK Cells in Advanced Prostate Cancer
DUAL-NK-PC
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
1 other identifier
interventional
36
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2026
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 2, 2026
CompletedFirst Submitted
Initial submission to the registry
June 6, 2026
CompletedFirst Posted
Study publicly available on registry
June 11, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 17, 2028
June 11, 2026
June 1, 2026
1 year
June 6, 2026
June 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incidence of dose-limiting toxicities (DLTs)
28 days
Incidence of treatment-emergent adverse events
12 months
Determination of maximum tolerated dose (MTD)
12 months
Secondary Outcomes (4)
Overall response rate by RECIST 1.1
12 months
Radiographic progression-free survival (rPFS)
12 months
Duration of response
12 months
Overall survival
24 months
Study Arms (2)
Dose Escalation
EXPERIMENTALParticipants receive fludarabine/cyclophosphamide lymphodepletion followed by a single IV infusion of ETB-DualNK-01 at escalating dose levels. Safety during the Day 28 DLT window determines escalation.
Dose Expansion
EXPERIMENTALParticipants receive ETB-DualNK-01 at the selected RP2D after the same lymphodepletion regimen. One optional repeat infusion may be permitted if predefined safety criteria are met.
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: 300 mg/m2/day IV on Days -5 to -3 before ETB-DualNK-01 infusion
Lymphodepletion regimen: 30 mg/m2/day IV on Days -5 to -3 before ETB-DualNK-01 infusion.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Biotechlead
Study Sites (1)
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- No masking is planned because this is an early-phase
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2026
First Posted
June 11, 2026
Study Start
March 2, 2026
Primary Completion (Estimated)
March 14, 2027
Study Completion (Estimated)
June 17, 2028
Last Updated
June 11, 2026
Record last verified: 2026-06