NCT05580796

KSH01-R02-101 Solid Tumors

Investigator Initiated Clinical Trial on the Tolerance, Safety and Preliminary Efficacy of KSH01-TCRT Injection in Solid Tumor Subjects

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: TCRx Therapeutics Co.Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

1. . safety and tolerance 2. . objective response rate

Detailed description

1. . To evaluate the safety and tolerance of autologous TCR-T cells in target positive solid tumor patients. 2. . Preliminary evaluation of objective response rate (ORR) of autologous TCR-T cells in target positive solid tumor patients (such as esophageal cancer, gastric cancer, head and neck cancer, bladder cancer, melanoma, sarcoma, etc.)

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	KSH01 injection	TCR-T cell injection

Timeline

• Start date: 2022-10-11
• Primary completion: 2025-10-11
• Completion: 2027-10-11
• First posted: 2022-10-14
• Last updated: 2023-04-03

Locations

1 site across 1 country: China