Metastatic Castration-resistant Prostate CancerPhase 1DUAL-NK-PCNCT07641049
Dual-target PSMA/PSCA CAR-NK Cells in Advanced Prostate Cancer
A Phase 1 study testing ETB-DualNK-01, Fludarabine and Cyclophosphamide in people with Metastatic Castration-resistant Prostate Cancer and Advanced Prostate Adenocarcinoma, run by Beijing Biotech at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer, Advanced Prostate Adenocarcinoma, PSCA-positive Prostate Cancer
- What is being tested?
- ETB-DualNK-01, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2026to 17 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Zhen J Peng, Phd, +86 13076790039, Zhen-Peng@beijing-biotech.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Metastatic Castration-resistant Prostate Cancer, Advanced Prostate Adenocarcinoma, PSCA-positive Prostate Cancer, PSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer
- Being tested
- ETB-DualNK-01, Fludarabine, Cyclophosphamide
- Keywords
- CAR-NK, dual-target, PSMA, PSCA, mCRPC, metastatic prostate cancer, cell therapy, immunotherapy, dose escalation, dose expansion
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETB-DualNK-01Biological
Also called Dual-target anti-PSMA/PSCA CAR-NK cells
Allogeneic dual-target antiPSMA/PSCA CAR-NK cells administered intravenously on Day 0; repeat infusion permitted only per protocol in Part B.
FludarabineDrug
Also called Fludara
Lymphodepletion regimen: 30 mg/m2/day IV on Days -5 to -3 before ETB-DualNK-01 infusion.
CyclophosphamideDrug
Also called Cytoxan
Lymphodepletion regimen: 300 mg/m2/day IV on Days -5 to -3 before ETB-DualNK-01 infusion
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | 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. Receives: Biological: ETB-DualNK-01; Drug: Fludarabine; Drug: Cyclophosphamide |
| Dose Expansion | Experimental | 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. Receives: Biological: ETB-DualNK-01; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs)
Measured: 28 days
Incidence of treatment-emergent adverse events
Measured: 12 months
Determination of maximum tolerated dose (MTD)
Measured: 12 months
Secondary outcomes (4)
Overall response rate by RECIST 1.1
Measured: 12 months
Radiographic progression-free survival (rPFS)
Measured: 12 months
Duration of response
Measured: 12 months
Overall survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start2 Mar 2026
- Primary completion14 Mar 2027 (estimated)
- Study completion17 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Part A: 3+3 dose-escalation of ETB-DualNK-01 after fludarabine/cyclophosphamide lymphodepletion. Part B:dose-expansion at the selected RP2D in biomarkerconfirmed disease.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641049
- Sponsor's protocol ID
- ETB-CARNK-PSMAPSCA-004
- Acronym
- DUAL-NK-PC
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07641049
- Acronym / sponsor ID
- DUAL-NK-PC / ETB-CARNK-PSMAPSCA-004
- Conditions
- Metastatic Castration-resistant Prostate Cancer, Advanced Prostate Adenocarcinoma, PSCA-positive Prostate Cancer, PSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer
- Keywords
- CAR-NK, dual-target, PSMA, PSCA, mCRPC, metastatic prostate cancer, cell therapy, immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Beijing BiotechIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 14 Mar 2027 (estimated)
- Study completion
- 17 Jun 2028 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Part A: 3+3 dose-escalation of ETB-DualNK-01 after fludarabine/cyclophosphamide lymphodepletion. Part B:dose-expansion at the selected RP2D in biomarkerconfirmed disease.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Biological: ETB-DualNK-01, Drug: Fludarabine, Drug: CyclophosphamideParticipants 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 | Experimental | Biological: ETB-DualNK-01, Drug: Fludarabine, Drug: CyclophosphamideParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ETB-DualNK-01Also: Dual-target anti-PSMA/PSCA CAR-NK cellsAllogeneic dual-target antiPSMA/PSCA CAR-NK cells administered intravenously on Day 0; repeat infusion permitted only per protocol in Part B. | Biological | Dose Escalation, Dose Expansion |
| FludarabineAlso: FludaraLymphodepletion regimen: 30 mg/m2/day IV on Days -5 to -3 before ETB-DualNK-01 infusion. | Drug | Dose Escalation, Dose Expansion |
| CyclophosphamideAlso: CytoxanLymphodepletion regimen: 300 mg/m2/day IV on Days -5 to -3 before ETB-DualNK-01 infusion | Drug | Dose Escalation, Dose Expansion |
Primary outcome
Incidence of dose-limiting toxicities (DLTs)
Time frame: 28 days
Incidence of treatment-emergent adverse events
Time frame: 12 months
Determination of maximum tolerated dose (MTD)
Time frame: 12 months
4 secondary outcomes
Overall response rate by RECIST 1.1
Time frame: 12 months
Radiographic progression-free survival (rPFS)
Time frame: 12 months
Duration of response
Time frame: 12 months
Overall survival
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ETB-DualNK-01, Fludarabine and Cyclophosphamide in people with Metastatic Castration-resistant Prostate Cancer and Advanced Prostate Adenocarcinoma, run by Beijing Biotech at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seni S Lu, Phd (+86 13076790030, Seni-Lu@beijing-biotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities (DLTs) (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.