NCT06643910

A Study on the Safety and Efficacy of BST08 in Treating Advanced Non-Small Cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: BioSyngen Pte Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is an exploratory clinical trial initiated by an open, single arm researcher to evaluate the safety, tolerability, and preliminary efficacy of BST08 in the treatment of advanced non-small cell lung cancer in subjects. This study plans to set up two experimental groups: monotherapy group A: 9x10 \^ 10 BST08 (3 cases) and combination therapy group B: 9x10 \^ 10 BST08+Pabolizhu 200mg Q3W (6 cases).

Detailed description

Main purpose: Evaluate the safety and tolerability of BST08 treatment in subjects with advanced non-small cell lung cancer. Secondary purpose: 1. Evaluate the preliminary effectiveness of BST08 in the treatment of advanced non-small cell lung cancer subjects; 2. Evaluate the pharmacokinetic (PK) characteristics of BST08.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Single drug group A	9x10\^10 BST08 cells, Intravenous infusion，3 subject is planned to be enrolled
BIOLOGICAL	Combined treatment group B	9x10\^10 BST08 cells+ Pembrolizumab Injection，200mg，Q3W, Intravenous infusion，6subject is planned to be enrolled

Timeline

• Start date: 2024-10-24
• Primary completion: 2026-08-31
• Completion: 2027-08-31
• First posted: 2024-10-16
• Last updated: 2024-10-16

Locations

1 site across 1 country: China