Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT06942143

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

Led by Guangzhou FineImmune Biotechnology Co., LTD. · Updated on 2025-09-03

15

Participants Needed

1

Research Sites

109 weeks

Total Duration

On this page

Sponsors

G

Guangzhou FineImmune Biotechnology Co., LTD.

Lead Sponsor

S

Sun Yat-Sen University Cancer Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent prior to any trial activities
  • Aged 18 to 75 years, male or female
  • Failed first-line cancer treatment
  • Measurable tumors per RECIST1.1 criteria
  • HLA-A*02 positive
  • NY-ESO-1 immunohistochemical staining positive rate ≥20%
  • ECOG performance status 0 or 1
  • Expected survival longer than 3 months
  • No antineoplastic drugs or treatments within 4 weeks before TCR-T infusion
  • Left ventricular ejection fraction ≥50% by echocardiography
  • Laboratory values meeting specified minimum levels for blood counts and liver/kidney function
  • Negative pregnancy test for women of childbearing potential and agreement to use effective contraception
  • Ability to regularly visit research institutions for testing and management during the trial
Not Eligible

You will not qualify if you...

  • Major surgery, chemotherapy, large area radiotherapy, immunotherapy, or biological therapy within 4 weeks before trial
  • Known allergies to any trial treatment components
  • Unresolved adverse events from prior treatments above grade 2 CTCAE
  • Poorly controlled hypertension or significant cardio-cerebrovascular disease
  • Recent stroke (within 6 months), myocardial infarction (within 6 months), unstable angina, congestive heart failure class II or higher, or severe arrhythmias
  • Significant ECG abnormalities or QTc interval ≥450 msec on three tests
  • Serious organic diseases or mental disorders
  • Active systemic infections including tuberculosis, HIV, or hepatitis A, B, or C
  • Autoimmune diseases judged unsuitable by investigators (except vitiligo)
  • Use of chronic systemic steroids or immunomodulatory agents within 4 weeks prior to cell therapy
  • History of organ transplantation, stem cell transplantation, or renal replacement therapy
  • Uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or liver failure
  • Alcohol or drug abuse
  • Pregnant or breastfeeding women
  • Medical conditions likely to impair study conduct as judged by investigators
  • Lack of legal capacity or limited legal capacity

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sun Yat-sen University Cancer Center

Guangzhou, Gaungdong, China, 510700

Actively Recruiting

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Research Team

Y

Ying Cheng

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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