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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Targeting PSMA CAR-NK cells
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, 不限, China
RECRUITINGOccurrence of treatment related adverse events as assessed by CTCAE v5.0
Defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
Time frame: Baseline to 1 year post infusion
The pharmacokinetic analysis of Anti-PSMA CAR-NK Cell
Changes in the number of CD56+/ CD3 Anti-PSMA CAR-NK Cell in peripheral blood over time
Time frame: Day-2-Day-1、Day0、Day2、Day7、Day9、Day14、Day16、Day21、Day28、Day60 and Day90 post infusion
The pharmacodynamics analysis of Anti-PSMA CAR NK Cell
Changes of total prostate specific antigen (tPSA) and free prostate specific antigen (fPSA) in peripheral blood
Time frame: Baseline to infusion date、Day0、Day1、Day2、Day7、Day8、Day9、Day14、Day15、Day16、Day21、Day28、Day60、Day90、Day120、Day180、Day270 and Day360
The proportion of patients with a decrease in PSA levels from baseline
PSA response rate
Time frame: Baseline toDay0、Day1、Day2、Day7、Day8、Day9、Day14、Day15、Day16、Day21、Day28、Day60、Day90、Day120、Day180、Day270 and Day360 post infusion
Progression-free survival (PFS) after Anti-PSMA CAR NK Cell infusion
Survival time of patients
Time frame: Baseline to 1 year post infusion
Time to clinical progression
The time from baseline to the appearance of increased PSA levels or imaging progression.
Time frame: Baseline to Day28、Day90、Day180、Day270 and Day360 post infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.