NCT06150365

Personalized KSX01-TCRT in Patients With Advanced Solid Tumors

Single Arm Clinical Study on the Safety and Efficacy of Personalized KSX01-TCRT in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This trial is a single arm, open phase I clinical study to investigate the safety and efficacy of personalized KSX01-TCRT in patients with advanced solid tumors. This experiment is divided into two parts: the dose increasing stage (Part A) and the dose expanding stage (Part B). For those enrolled in the planned expansion phase, the dose should have passed the safety assessment during the dose escalation phase.

Conditions

• Refractory Solid Tumors
• Relapsed Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	KSX01-TCRT cell therapy	Patient autologous T cell therapy

Timeline

• Start date: 2023-11-07
• Primary completion: 2026-12-01
• Completion: 2028-12-01
• First posted: 2023-11-29
• Last updated: 2025-03-26

Locations

1 site across 1 country: China