Dual-target PSMA/PSCA CAR-NK Cells in Advanced Prostate Cancer (DUAL-NK-PC)

June 6, 2026 updated by: Beijing Biotech

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PSMA is the most clinically validated cell-surface target in advanced prostate cancer, while PSCA provides a complementary prostate-associated antigen with direct phase 1 cell-therapy precedent in mCRPC.

Dual recognition is intended to improve tumor coverage and reduce the risk of antigen escape across heterogeneous metastatic lesions.

Eligible participants will undergo screening to confirm metastatic CRPC, document PSMA and/or PSCA expression, establish baseline PSA and imaging status, and verify adequate organ function. Ongoing androgen deprivation therapy will be maintained to preserve castrate testosterone levels throughout study treatment.

Participants will receive lymphodepletion with fludarabine and cyclophosphamide followed by intravenous ETBDualNK-01 on Day 0. In the dose-expansion part, one optional repeat infusion may be allowed after protocoldefined safety review to improve NK-cell persistence. Imaging and PSA assessments will occur every 8 weeks during the first 6 months and every 12 weeks thereafter.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518036

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation
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.
Biological: 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.
Other Names:
  • Dual-target anti-PSMA/PSCA CAR-NK cells
Drug: Fludarabine
Lymphodepletion regimen: 30 mg/m2/day IV on Days -5 to -3 before ETB-DualNK-01 infusion.
Other Names:
  • Fludara
Drug: Cyclophosphamide
Lymphodepletion regimen: 300 mg/m2/day IV on Days -5 to -3 before ETB-DualNK-01 infusion
Other Names:
  • Cytoxan
Experimental: Dose Expansion
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.
Biological: 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.
Other Names:
  • Dual-target anti-PSMA/PSCA CAR-NK cells
Drug: Fludarabine
Lymphodepletion regimen: 30 mg/m2/day IV on Days -5 to -3 before ETB-DualNK-01 infusion.
Other Names:
  • Fludara
Drug: Cyclophosphamide
Lymphodepletion regimen: 300 mg/m2/day IV on Days -5 to -3 before ETB-DualNK-01 infusion
Other Names:
  • Cytoxan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of dose-limiting toxicities (DLTs)
Time Frame: 28 days
28 days
Incidence of treatment-emergent adverse events
Time Frame: 12 months
12 months
Determination of maximum tolerated dose (MTD)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of response
Time Frame: 12 months
12 months
Overall survival
Time Frame: 24 months
24 months
Radiographic progression-free survival (rPFS)
Time Frame: 12 months
12 months
Overall response rate by RECIST 1.1
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Biotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2026

Primary Completion (Estimated)

March 14, 2027

Study Completion (Estimated)

June 17, 2028

Study Registration Dates

First Submitted

June 6, 2026

First Submitted That Met QC Criteria

June 6, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 6, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETB-CARNK-PSMAPSCA-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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