An Exploratory Clinical Study Evaluating the Safety and Efficacy of Allogeneic CAR-NK Cell
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 sta
| Condition(s) | Prostate Cancer Castration-resistant Prostate Cancer |
|---|---|
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Study type | Interventional |
| 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 canc |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Locations | Beijing, 不限, China |
| Start date | 2025-12-18 |
| NCT ID | NCT07298239 |
| Official listing | https://clinicaltrials.gov/study/NCT07298239 |