RecruitingPhase 1NCT06942143

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

Sponsor

Guangzhou FineImmune Biotechnology Co., LTD.

Enrollment

15 participants

Start Date

May 22, 2025

Study Type

INTERVENTIONAL

Conditions

Lung Cancers Sarcoma Melanoma

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase I trial is testing Super1 TCR-T therapy — immune cells from your own blood that are genetically engineered to attack a cancer protein called NY-ESO-1 — in patients with advanced solid tumors that have failed prior treatment. **You may be eligible if...** - You are aged 18–75 - Your tumor tests positive for a protein called NY-ESO-1 (at least 20% of cells staining positive) - You test positive for a specific immune marker called HLA-A*02 - Your cancer has not responded to first-line treatment - You have measurable disease on scans and a good performance status (ECOG 0–1) - Your heart function is adequate (ejection fraction at least 50%) **You may NOT be eligible if...** - Your tumor is NY-ESO-1-negative or HLA-A*02-negative - You have brain metastases - You have severe heart, liver, kidney, or lung problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALSuper1 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.