NCT06350838

Clinical Study to Investigate the Safety and Tolerance of Therapeutic BCG in Postoperative Adjuvant Therapy in Subjects With Moderate to High-risk Non-muscular Invasive Bladder Cancer (NMIBC)

A Phase I Clinical Study to Investigate the Safety and Tolerance of Therapeutic Bacillus Calmette-Guerin( BCG) in Postoperative Adjuvant Therapy in Subjects With Moderate to High-risk Non-muscular Invasive Bladder Cancer (NMIBC)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Chengdu CoenBiotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Phase I clinical study to investigate the safety and tolerance of therapeutic BCG in postoperative adjuvant therapy in subjects with moderate to high-risk non-muscular invasive bladder cancer (NMIBC)

Detailed description

The purpose of this study was to evaluate the safety and tolerance, pharmacokinetic characteristics, ablative status, and immune response characteristics of the therapeutic BCG in postoperative adjuvant therapy in subjects with moderate and high-risk non-invasive bladder cancer (NMIBC). The study consisted of three phases: screening period, administration observation period and safety follow-up period. subjects will be treated with 120 mg BCG.

Conditions

• Non-muscular Invasive Bladder Cancer

Interventions

Type	Name	Description
DRUG	BCG for Therapeutic Use	Take 120 mg BCG for treatment, dissolved in 40 \~ 50 mL normal saline, bladder perfusion through catheter. The injection was performed once a week for 6 consecutive times.

Timeline

• Start date: 2022-11-11
• Primary completion: 2023-02-13
• Completion: 2023-02-13
• First posted: 2024-04-05
• Last updated: 2024-04-05

Locations

1 site across 1 country: China