Study of Allogeneic Anti-PSMA CAR-NK Cell for Metastatic Castration-Resistant Prostate Cancer

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • anti-PSMA CAR-NK

Treatment groups

10 Participants
are divided into 1 treatment group