Actively Recruiting
NY-ESO-1 TCR-T Cells for NY-ESO-1 Positive Subjects With Advanced Solid Tumors
Led by TCRCure Biopharma Ltd. · Updated on 2025-07-16
18
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
Sponsors
T
TCRCure Biopharma Ltd.
Lead Sponsor
C
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1) is a cancer-testis antigen (CTA) which is expressed in various tumors. In TCR-T therapy, researchers take the blood of a certain patient, select T cells and insert genes into the cell that expressing a kind of protein that targeting NY-ESO-1. The genetically engineered cells are called NY-ESO-1 TCR-T cells. Then the engineered cells are re-infused to the cancer patients to cure the disease or prolong life.
CONDITIONS
Official Title
NY-ESO-1 TCR-T Cells for NY-ESO-1 Positive Subjects With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign informed consent and follow trial procedures
- Age between 18 and 70 years
- Expected to survive more than 3 months
- ECOG performance status of 0 or 1
- Histologically confirmed metastatic or recurrent solid tumors
- Tumors resistant to standard treatments as shown by imaging
- Ability to provide fresh or preserved tissue samples
- At least one measurable tumor lesion per RECIST 1.1 criteria
- Positive NY-ESO-1 expression with ≥25% positive cells and staining intensity "++" or higher
- HLA-A2 type (excluding HLA-A*0203)
- Adequate blood counts: neutrophils ≥1.5×10⁹/L, platelets ≥75×10⁹/L, hemoglobin ≥90 g/L
- Normal liver and kidney function within defined limits
- Normal blood clotting tests (PT, INR, APTT ≤1.5 times upper normal limit)
- Heart function with left ventricular ejection fraction >45%
- Women of childbearing potential must use contraception or abstain from pregnancy from consent until 24 weeks after last drug administration
- Recovery from toxic effects of prior treatments before TC-N201 infusion
- Suitable for catheter insertion and no contraindications for white blood cell collection
You will not qualify if you...
- Pregnant or breastfeeding, or positive pregnancy test
- Severe allergy to ingredients used in the trial
- Participation in other investigational treatments within 4 weeks or concurrent clinical trials
- History of other malignancies within 5 years except cured localized tumors
- Primary central nervous system cancer or metastasis after localized treatment
- Active or history of autoimmune diseases requiring systemic steroids or immunosuppressants
- Immunodeficiency including HIV infection
- Grade 3 or higher thromboembolic events within 2 years or ongoing thrombolysis
- Hereditary or acquired bleeding disorders
- Clinical cardiovascular disease or symptoms
- Active infection needing systemic treatment, except cancer-related fever
- Active or recent pulmonary tuberculosis infection within 1 year or untreated history
- Positive for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or syphilis antibody
- Major surgery or severe injury within 4 weeks before TC-N201 infusion
- Receipt of live or attenuated vaccines within 28 days before leukapheresis
- History of drug addiction, alcoholism, or substance abuse
- Previous cell therapy such as TCR-T, CAR-T, or TIL
- Prior treatment targeting NY-ESO-1
- Deemed unsuitable for the trial by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
TCRCure Biopharma Ltd.
Chongqing, China
Actively Recruiting
Research Team
N
ning Li, PhD
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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