Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Prostate Adenocarcinoma | Prostate Adenocarcinoma | CURATED_BROADER | 0.78 |
| Metastatic Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
| PSCA-positive Prostate Cancer | — | UNRESOLVED | — |
| PSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| ETB-DualNK-01 | Biological | — | UNRESOLVED |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- Participants 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.
- interventionNames
- Biological: ETB-DualNK-01
- Drug: Fludarabine
- Drug: Cyclophosphamide
- type
- EXPERIMENTAL
- label
- Dose Expansion
- description
- Participants 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.
- interventionNames
- Biological: ETB-DualNK-01
- Drug: Fludarabine
- Drug: Cyclophosphamide
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available