RecruitingEarly Phase 1NCT07298239

An Exploratory Clinical Study Evaluating the Safety and Efficacy of Allogeneic CAR-NK Cell Therapy for Metastatic Castration-resistant Prostate Cancer (mCRPC)

A Single-Center, Open-Label, Single-Arm, Exploratory Clinical Study to Evaluate the Safety and Efficacy of Allogeneic CAR-NK Cell Therapy in Metastatic Castration-Resistant Prostate Cancer (mCRPC)


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

15 participants

Start Date

Dec 18, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new CAR-NK cell therapy — a type of immune cell therapy made from donor cells that are engineered to attack cancer — in men with metastatic castration-resistant prostate cancer (prostate cancer that has spread and no longer responds to hormone therapy). **You may be eligible if...** - You are a man aged 18 or older - You have metastatic prostate cancer that is no longer responding to hormone therapy (castration-resistant) - Your testosterone level is at a very low (castration) level - Your PSA levels have been rising despite treatment - You have had prior treatment with standard medications for this stage of prostate cancer **You may NOT be eligible if...** - You have significant autoimmune conditions - You have uncontrolled active infections - You have serious heart problems - You are participating in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALanti-PSMA CAR-NK

Targeting PSMA CAR-NK cells


Locations(1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, 不限, China

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NCT07298239


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