NCT05533203

Safety of Prodencel in the Treatment of Metastatic Castration-resistant Prostate Cancer (mCRPC)

A Multicenter, Non-randomized, Open-label, and Dose-escalation Phase I Study to Evaluate the Safety of Prodencel Treatment in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Shanghai Humantech Biotechnology Co. Ltd · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Metastatic Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Prodencel; an autologous dendritic cell therapeutic tumor vaccine	Subcutaneous injection, each injection point should not exceed 1ml.

Timeline

• Start date: 2022-08-08
• Primary completion: 2023-08-30
• Completion: 2024-03-01
• First posted: 2022-09-08
• Last updated: 2023-01-23

Locations

1 site across 1 country: China