Clareo Health | An Exploratory Clinical Study Evaluating the Safety and Efficacy of Allogeneic CAR-NK Cell Therapy for Metastatic Castration-resistant Prostate Cancer (mCRPC)
An Exploratory Clinical Study Evaluating the Safety and Efficacy of Allogeneic CAR-NK Cell Therapy for Metastatic Castration-resistant Prostate Cancer (mCRPC)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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).
Voluntarily participate, provide written informed consent, and be able to comply with follow-up.
You may not be if
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 T-cell immunotherapy (CAR-T), etc.;
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 aminotransferase (AST) ≥ 2.5 × the upper limit of normal (ULN) (or ≥ 5 × ULN for subjects with liver metastases); c. Renal function: Serum creatinine (Cr) ≥ 1.5 × ULN; d. Coagulation function: Prothrombin time (PT), Activated partial thromboplastin time (APTT), International Normalized Ratio (INR) ≥ 1.5 × ULN;
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 within the past week;
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;
Subjects deemed by the investigator to be unsuitable for participation in this study for other reasons.
