NCT07139067

Phase I Clinical Study of YK1101 Injection for the Treatment of Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A single-arm, open-label, dose exploratory study to evaluate the safety, efficacy, and pharmacokinetics of autologous humanized anti-MAGE-A4 T cell receptor-engineered T cell (TCR-T) in advanced solid tumors.

Detailed description

This study is a single-arm, open-label, dose escalation/dose regimen finding study to assess the safety and pharmacokinetics of T-cell receptor-engineered T cell (TCR-T) targeting melanoma-associated antigen-4 (MAGE-A4) and to obtain the preliminary efficacy results in subjects who have been diagnosed with advanced solid tumors with positive MAGE-A4 expression.

Conditions

• Advanced Solid Tumor Cancer

Interventions

Type	Name	Description
BIOLOGICAL	YK1101 cells	Drug: Fludarabine + Cyclophosphamide

Timeline

• Start date: 2025-04-27
• Primary completion: 2026-07-01
• Completion: 2028-07-01
• First posted: 2025-08-24
• Last updated: 2025-08-24

Locations

2 sites across 1 country: China