NCT07641049 Dual-target PSMA/PSCA CAR-NK Cells in Advanced Prostate Cancer
| NCT ID | NCT07641049 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Beijing Biotech |
| Condition | Metastatic Castration-resistant Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2026-03-02 |
| Primary Completion | 2027-03-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2026-03-02 with a primary completion date of 2027-03-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07641049 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Metastatic Castration-resistant Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07641049 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07641049 currently recruiting?
Yes, NCT07641049 is actively recruiting participants. Contact the research team at Seni-Lu@beijing-biotech.com for enrollment information.
Where is the NCT07641049 trial being conducted?
This trial is being conducted at Shenzhen, China.
Who is sponsoring the NCT07641049 clinical trial?
NCT07641049 is sponsored by Beijing Biotech. The trial plans to enroll 36 participants.
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