At present, no cell drug with an indication for mCRPC has been approved for marketing in China, and there is no scholar to fight against it PSMA-CAR-NK cell therapy CRPC was reported in a study. Based on the previous basic research, our company has developed CAR-NK cell injection, hoping to further evaluate its safety, tolerability and preliminary efficacy in the treatment of mCRPC patients in clinical studies, and provide new possibilities for the selection of clinical treatment strategies
diagnosed metastatic castration-resistant prostate cancer (mCRPC);
Castration level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L);
Positive expression of PSMA;
Expected survival time ≥6 months;
Previous recipients of other cell therapy products, such as dendritic cells (DC), multiple cytokine-induced killer cells (CIK), T cells, natural killer cells (NK), chimeric antigen receptor T-cell immunotherapy (CAR-T), etc.;
Patients with a history of biological macromolecule drug allergy;
Previous treatment with any PSMA-targeted therapy;
active autoimmune diseases (including connective tissue disease, uveitis, sarcoidosis, inflammatory bowel disease, or multiple sclerosis) or need long-term immunosuppressive therapy of severe autoimmune disease (screening clinic within six weeks before any immunosuppressive therapy), or by the researchers determine in 3 months will be recurrence of subjects;
Single group
anti-PSMA CAR-NK
Biological/VaccineTargeting PSMA CAR-NK cells
Occurrence 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
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
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
The proportion of patients with a decrease in PSA levels from baseline
PSA response rate
Progression-free survival (PFS) after Anti-PSMA CAR NK Cell infusion
Survival time of patients
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