NCT06942143

An Open-label, Phase I Clinical Trial of Super1 TCR-T in NY-ESO-1-positive Patients With Advanced Solid Tumors

An Open-label, Phase I Clinical Trial of Autologous T Cells Transduced With NY-ESO-1 Antigen-specific High-affinity T Cell Receptors in NY-ESO-1-positive Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Guangzhou FineImmune Biotechnology Co., LTD. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation.

Detailed description

After the subjects signed the informed consent form, the HLA genotype of the subjects was detected. After the HLA genotype was confirmed as A\*02, the tumor tissue was detected by immunohistochemistry. The subjects could proceed to the subsequent clinical trial if the NY-ESO-1 immunohistochemistry was positive. Each subject received only one cell reinfusion.

Conditions

• Sarcoma
• Lung Cancers
• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Super1 TCR-T	All participators received lymphoid-depleted preconditioning before Super1 TCR-T cells infusion. Super1 TCR-T cells were infused 3 days later. Concomitant administration of interleukin for 7 consecutive days.

Timeline

• Start date: 2025-05-22
• Primary completion: 2027-04-25
• Completion: 2027-06-25
• First posted: 2025-04-24
• Last updated: 2025-09-03

Locations

1 site across 1 country: China