Prostatic Neoplasms Clinical Trial
Official title:
A Pilot Study of Hormonal Therapy Combined With Central Memory T Cells (Tcm) for Patients With Advanced Prostate Cancer
The purpose of this study is to evaluate the feasibility, safety and oncological efficacy of hormonal therapy combined with autologous Tcm cells for patients with advanced prostate cancer.
Adoptive cancer immunotherapy,the infusion of tumor-reactive T cells to patients,represents a
promising approach for the treatment of advanced metastatic disease.It has been shown that
central memory T cells (Tcm) were the optimal antitumor T cells for adoptive cell transfer in
cancer patients.However,the potential of autologous Tcm cells to treat the advanced prostate
cancer has not been evaluated.
This is an open-label pilot study to determine if the infusion of autologous Tcm cells
combined with hormonal therapy is safe and effective for the treatment of advanced prostate
cancer.This study will have the following two cohorts:Cohort A) metastatic hormone-sensitive
prostate cancer (mHSPC) treated with maximal androgen blockade plus autologous Tcm cells and
Cohort B) metastatic castration-resistant prostate cancer (mCRPC) treated with abiraterone
acetate plus autologous Tcm cells.A total of 60 evaluable subjects will be enrolled over an
enrollment period of 24 months.The study is planned to enroll approximately 30 evaluable
subjects in each treatment cohort.
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