Actively Recruiting
An Exploratory Clinical Study Evaluating the Safety and Efficacy of Allogeneic CAR-NK Cell Therapy for Metastatic Castration-resistant Prostate Cancer (mCRPC)
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-01-22
15
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Exploratory Clinical Study Evaluating the Safety and Efficacy of Allogeneic CAR-NK Cell Therapy for Metastatic Castration-resistant Prostate Cancer (mCRPC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 years or older
- Diagnosed with metastatic castration-resistant prostate cancer (mCRPC) with serum testosterone at castration level (< 50 ng/dL or < 1.7 nmol/L)
- Evidence of disease progression by PSA increase or new lesions on bone scan or soft tissue
- Expected survival of at least 6 months
- ECOG performance status between 0 and 2
- Positive prostate-specific membrane antigen (PSMA) expression
- Able and willing to provide written informed consent and comply with study follow-up
You will not qualify if you...
- Prior treatment with other cell therapy products such as dendritic cells, cytokine-induced killer cells, T cells, natural killer cells, or CAR-T therapy
- History of other cancers within 5 years except resolved carcinoma in situ or slow-progressing malignancies
- Abnormal major organ function including low neutrophil count, low platelets, low hemoglobin, elevated liver enzymes, impaired kidney function, or coagulation abnormalities
- Active infections currently treated or recent infections requiring prolonged antibiotics
- Active autoimmune disease or history of severe autoimmune disease needing long-term immunosuppression
- Participation in another clinical trial within the past 3 months
- Inability to use effective contraception
- History of allergy to biologic macromolecular drugs
- Untreated or active hepatitis B or C infection
- Any other condition deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, 不限, China, 100000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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