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Clinical Trial Summary

This phase I clinical trial is to evaluate the safety of Prodencel (an autologous dendritic cell therapeutic tumor vaccine.) in patients with metastatic castration-resistant prostate cancer (mCRPC).


Clinical Trial Description

This is a single arm pilot study to evaluate the safety of delivering a dendritic cell vaccine in fifteen to twenty-four (n=15-24) adult patients diagnosed with prostate adenocarcinoma after novel androgen-deprived therapy and docetaxel chemotherapy failure. The study is constructed in a 3+3 design for three steps of dose escalation with rigorous and mandatory safety monitoring. Subjects received the vaccine at a dose of 5-15×10^6 cells every two weeks for a total of 3 doses. A dose from cohort 1-3 is recommended for booster immunization every 4 weeks until disease progression or intolerance, to evaluate the safety and tolerability of the booster immunization of Prodencel. Subjects will be monitored for adverse events as dictated by CTCAE version 5. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05533203
Study type Interventional
Source Shanghai Humantech Biotechnology Co. Ltd
Contact Guoyou Chen, Ph.D.
Phone +86 13601923503
Email guoyouchen@humtech.com.cn
Status Recruiting
Phase Phase 1
Start date August 8, 2022
Completion date March 1, 2024

See also
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