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Tests treatment safety and results for Prostate Cancer Castration-resistant Prostate Cancer
Official title An Exploratory Clinical Study Evaluating the Safety and Efficacy of Allogeneic CAR-NK Cell Therapy for Metastatic Castration-resistant Prostate Cancer (mCRPC)
ClinicalTrials.gov ID: NCT07298239
What this study is testing
What is anti-PSMA CAR-NK?
anti-PSMA CAR-NK is an investigational medicine, being studied as a potential treatment for prostate cancer castration-resistant prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Age ≥ 18 years, male;
- Diagnosis of metastatic castration-resistant prostate cancer (mCRPC) meeting the following criteria: ① Serum testosterone at castration level: \ 2...
- Expected survival ≥ 6 months;
- ECOG performance status of 0-2;
- Positive prostate-specific membrane antigen (PSMA) expression;
You likely can't join if
- Prior treatment with other cell therapy products besides the investigational product, such as dendritic cells (DC), cytokine-induced killer cells...
- History of other malignancies within 5 years prior to screening (except for completely resolved carcinoma in situ or malignancies deemed by the...
- 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...
- Any currently treated active (viral, bacterial, fungal) infection, or any infection within the past 6 weeks requiring intravenous antibiotics for 7...
- Active autoimmune disease, or history of severe autoimmune disease requiring long-term immunosuppressive therapy;
- Participation in another clinical trial study within 3 months;
See the full eligibility criteria
- Age ≥ 18 years, male;
- Diagnosis of metastatic castration-resistant prostate cancer (mCRPC) meeting the following criteria: ① Serum testosterone at castration level: \ 2 ng/mL; b. Radiographic progression: Two or more new lesions detected on...
- 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.
- 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...
- 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...
- 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...
- 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;
- people deemed by the investigator to be unsuitable for participation in this study for other reasons.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 不限, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, 不限, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.