NCT07298239 An Exploratory Clinical Study Evaluating the Safety and Efficacy of Allogeneic CAR-NK Cell Therapy for Metastatic Castration-resistant Prostate Cancer (mCRPC)
| NCT ID | NCT07298239 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Prostate Cancer Castration-resistant Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-12-18 |
| Primary Completion | 2028-04-01 |
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 15 participants in total. It began in 2025-12-18 with a primary completion date of 2028-04-01.
⚠ 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 study introduces a new treatment approach for metastatic castration-resistant prostate cancer, a stage of disease that remains difficult to manage with current therapies. Prostate cancer is the second most common cancer in men worldwide, and many patients eventually progress to an advanced, treatment-resistant stage despite hormone therapy, newer hormonal agents, or chemotherapy. Patients with metastatic castration-resistant disease often face a poor prognosis, complications such as bone metastases, and significant impacts on quality of life, highlighting the urgent need for new treatment options. This research focuses on an innovative immunotherapy using allogeneic anti-PSMA CAR-NK cells, which are engineered natural killer cells designed to precisely recognize and kill prostate cancer cells expressing the prostate-specific membrane antigen. CAR-NK cells combine the natural tumor-killing ability of NK cells with enhanced targeting and reduced immune escape, offering a potentially safer and more effective strategy. Through this clinical study, the safety, tolerability, and preliminary effectiveness of anti-PSMA CAR-NK cell therapy will be evaluated, aiming to provide new evidence and expand future treatment possibilities for patients with advanced prostate cancer.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years, male; * Diagnosis of metastatic castration-resistant prostate cancer (mCRPC) meeting the following criteria: ① Serum testosterone at castration level: \< 50 ng/dL or \< 1.7 nmol/L; ② Meeting any one of the following conditions: a. PSA progression: Three consecutive rises in PSA measured at intervals of at least 1 week, with two increases being ≥ 50% above the PSA nadir, and a PSA value \> 2 ng/mL; b. Radiographic progression: Two or more new lesions detected on bone scan, or an increase in soft tissue lesions assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST). * Expected survival ≥ 6 months; * ECOG performance status of 0-2; * Positive prostate-specific membrane antigen (PSMA) expression; * Voluntarily participate, provide written informed consent, and be able to comply with follow-up. Exclusion Criteria: * Prior treatment with other cell therapy products besides the investigational product, such as dendritic cells (DC), cytokine-induced killer cells (CIK), T cells, natural killer cells (NK), chimeric antigen receptor T-cell immunotherapy (CAR-T), etc.; * History of other malignancies within 5 years prior to screening (except for completely resolved carcinoma in situ or malignancies deemed by the investigator to be slow-progressing); * Abnormal function of major organs: a. Absolute neutrophil count (ANC) \< 1.5 × 10⁹/L; Platelet count (Plt) \< 100 × 10⁹/L; Hemoglobin (Hb) \< 9 g/dL; b. Liver function: Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≥ 2.5 × the upper limit of normal (ULN) (or ≥ 5 × ULN for subjects with liver metastases); c. Renal function: Serum creatinine (Cr) ≥ 1.5 × ULN; d. Coagulation function: Prothrombin time (PT), Activated partial thromboplastin time (APTT), International Normalized Ratio (INR) ≥ 1.5 × ULN; * Any currently treated active (viral, bacterial, fungal) infection, or any infection within the past 6 weeks requiring intravenous antibiotics for 7 days or longer, or any active infection requiring oral antibiotics within the past week; * Active autoimmune disease, or history of severe autoimmune disease requiring long-term immunosuppressive therapy; * Participation in another clinical trial study within 3 months; * Inability to employ effective contraceptive measures; * History of hypersensitivity to biologic macromolecular drugs; * Untreated chronic active hepatitis B, or chronic hepatitis B virus carriers with HBV DNA ≥ 1000 copies/mL, or patients with active hepatitis C; * Subjects deemed by the investigator to be unsuitable for participation in this study for other reasons.
Frequently Asked Questions
Who can join the NCT07298239 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer 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 NCT07298239 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 NCT07298239 currently recruiting?
Yes, NCT07298239 is actively recruiting participants. Visit ClinicalTrials.gov or contact Cancer Institute and Hospital, Chinese Academy of Medical Sciences to inquire about joining.
Where is the NCT07298239 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07298239 clinical trial?
NCT07298239 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 15 participants.
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