Actively Recruiting
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
Led by Guangzhou FineImmune Biotechnology Co., LTD. · Updated on 2025-09-03
15
Participants Needed
1
Research Sites
8 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
Researchers are conducting a phase I clinical trial to evaluate the safety and tolerability of Super1 TCR-T cells in patients with advanced solid tumors who are positive for the NY-ESO-1 antigen. This open-label, single-center study involves a dose escalation design to assess treatment effects in patients with sarcoma, lung cancers, or melanoma who have experienced first-line treatment failure. The trial includes patients aged 18 to 75 years with measurable tumors and specific genetic markers. Participants receive a lymphoid-depleting preconditioning regimen before receiving an infusion of Super1 TCR-T cells, followed by seven days of interleukin administration. The treatment dose is escalated in a 3+3 design across three dose levels, with each participant receiving only one cell reinfusion. Prior to enrollment, patients undergo HLA genotype testing and tumor tissue immunohistochemistry to confirm eligibility based on HLA-A*02 status and NY-ESO-1 positivity. Throughout the study, participants undergo regular testing, evaluations, and management visits as scheduled by the research institution. Researchers monitor dose-limiting toxicities and maximum tolerated doses within 28 days after treatment. Longer-term outcomes such as overall response rate, overall survival, and progression-free survival are assessed up to one year after cell reinfusion. Safety and treatment effects are closely tracked during the trial period, which concludes in mid-2027.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any trial activities
- Age between 18 and 75 years, male or female
- Patients with first-line treatment failure
- Measurable lesions per RECIST 1.1 criteria
- HLA-A*02 positive
- NY-ESO-1 immunohistochemical staining positive at 20% or higher
- ECOG performance status 0-1
- Expected survival time over 3 months
- No antineoplastic drugs or treatments within 4 weeks before TCR-T infusion
- Left ventricular ejection fraction 50% or higher by echocardiography
- Laboratory values meeting specified thresholds for blood counts, coagulation, kidney and liver function
- Negative pregnancy test for women of childbearing potential and agreement to use effective contraception
- Commitment to regular study visits and evaluations during the trial
You will not qualify if you...
- Major surgery, chemotherapy, radiotherapy, immunotherapy, or biological therapy within 4 weeks before trial
- Known allergies to any trial treatment components
- Incomplete recovery from prior surgery or treatment-related adverse events above grade 2
- Poorly controlled hypertension or significant cardio-cerebrovascular disease
- Recent serious cardiovascular events within 6 months
- Significant ECG abnormalities or prolonged QTc interval
- Serious organic diseases or mental disorders
- Active systemic infections including tuberculosis, HIV, hepatitis A, B, or C
- History of autoimmune diseases unsuitable for the study (except vitiligo)
- Use of systemic corticosteroids or immunomodulatory agents within 4 weeks prior to therapy
- History of organ transplantation or stem cell transplantation
- Uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or liver failure
- Known alcohol or drug abuse
- Pregnant or breastfeeding women
- Other medical conditions judged to impair study participation
- Lack of legal capacity or limited capacity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days
Participants receive lymphoid-depleting preconditioning, followed by infusion of Super1 TCR-T cells three days later and concomitant interleukin administration for 7 consecutive days.
Approximately 10 visits including preconditioning, infusion, and interleukin administration
Duration - Up to 1 year
Participants are monitored for treatment response and safety outcomes for up to one year after cell reinfusion.
Regular visits during the year after treatment
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Gaungdong, China, 510700
Actively Recruiting
Research Team
Y
Ying Cheng
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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