Super1 TCR-T for NY-ESO-1–positive 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
This trial tests whether a single infusion of Super1 TCR-T can help people with advanced sarcoma, lung cancer, or melanoma whose tumors are HLA-A*02 positive and express NY-ESO-1.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Guangzhou FineImmune Biotechnology Co., LTD. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou, Gaungdong) |
| Trial ID | NCT06942143 on ClinicalTrials.gov |
What this trial studies
This was a Phase I, open-label, single-center dose-escalation (3+3) trial of Super1 TCR-T in patients with advanced solid tumors. After consent, participants underwent HLA genotyping and tumor immunohistochemistry, and only HLA-A*02 patients with NY-ESO-1 IHC ≥20% proceeded. Eligible patients (ECOG 0–1, measurable disease per RECIST 1.1, adequate labs and cardiac function) received a single autologous Super1 TCR-T infusion following a washout from prior antineoplastic therapy. The primary focus was safety and tolerability with dose escalation to define a recommended dose level.
Who should consider this trial
Good fit: Ideal candidates are adults (18–75) with advanced sarcoma, lung cancer, or melanoma who have failed first-line therapy, are HLA-A*02 positive, have NY-ESO-1 IHC ≥20%, ECOG 0–1, and meet specified laboratory and cardiac criteria.
Not a fit: Patients who are not HLA-A*02, whose tumors lack significant NY-ESO-1 expression, who have poor performance status, active uncontrolled comorbidities, recent antineoplastic therapy, or inadequate labs are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could produce tumor responses or durable control for a subset of antigen-positive, HLA-A*02 patients who have exhausted first-line options.
How similar studies have performed: Prior early-phase TCR-T programs targeting NY-ESO-1 have produced objective responses in sarcoma and melanoma cohorts, though outcomes have varied across studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Sign informed consent before conducting any trial-related activities;
2. Age of 18-75 years old, male or female;
3. Patients with first-line treatment failure;
4. Measurable lesions according to RECIST1.1 criteria.
5. During the trial screening period, the following two screening criteria must be met (by the sponsor) :
* HLA-A\*02 positive;
* The positive rate of NYESO-1 immunohistochemical staining was ≥20%.
6. ECOG score 0-1;
7. The expected survival time is more than 3 months;
8. Antineoplastic drugs and treatments were not allowed for 4 weeks before TCR-T cell infusion;
9. Echocardiography showed left ventricular ejection fraction ≥50%;
10. Laboratory test results should at least meet the following specified indicators:
* WBC ≥3.0×109/L;
* Absolute neutrophil count (ANC) ≥1.5×109/L;
* Absolute lymphocyte count (ALC) ≥1.0×109/L;
* platelet (PLT) ≥75×109/L;
* hemoglobin ≥10g/dL (no blood transfusion in the past 7 days);
* Prothrombin time or INR≤1.5x upper limit of normal unless receiving anticoagulant therapy;
* Partial prothrombin time (APTT) ≤1.5x upper limit of normal time, unless receiving anticoagulant therapy;
* 24-hour creatinine clearance ≥60mL/ min;
* Aspartate aminotransferase (AST/SGOT) ≤2.5×ULN;
* alanine aminotransferase (ALT/SGPT) ≤2.5×ULN;
* Total bilirubin (TBIL) ≤1.5×ULN
11. Negative pregnancy tests in women of childbearing potential prior to study treatment; Consent must be given to use effective contraception during treatment.
12. During the whole period of the trial, I can regularly visit the enrolled research institutions for relevant testing, evaluation and management.
Exclusion Criteria:
1. Patients who received major surgery, conventional chemotherapy, large area radiotherapy, immunotherapy or biological therapy within 4 weeks before entering the trial;
2. Known to produce allergic reactions to any component of the trial treatment;
3. no recovery from previous surgery or treatment-related adverse events to ≤ grade 2 CTCAE;
4. Poorly controlled hypertension (systolic blood pressure \> 160mmHg and/or diastolic blood pressure \> 90mmHg) or clinically significant (e.g., active) cardio-cerebrovascular disease; Cerebrovascular accident (within 6 months before the signing of informed consent), myocardial infarction (within 6 months before the signing of informed consent), unstable angina, congestive heart failure of New York Heart Association class II or higher (Appendix), or severe arrhythmia that could not be controlled with medications or that had the potential to affect study treatment; Electrocardiogram (ECG) was significantly abnormal or the mean QTc interval was ≥450 msec on three consecutive occasions.
5. Combined with other serious organic diseases and mental disorders;
6. Have active systemic infection requiring treatment, including active tuberculosis, known HIV positivity, or clinically active hepatitis A, B, or C; (Virus carriers should be excluded)
7. Patients with autoimmune diseases: those with a history of inflammatory bowel disease or a history of autoimmune diseases (such as systemic lupus erythematosus, vasculitis, and invasive lung disease) judged by the investigators to be not suitable for this study should be excluded; (Patients with vitiligo are not excluded).
8. Administration of chronic systemic cortisone steroids, hydroxyurea, and immunomodulatory agents (e.g., interleukin-2, interferon-α or γ, GM-CSF, mTOR inhibitors, cyclosporine, thymosin, etc.) within 4 weeks prior to cell therapy."
9. History of organ transplantation, autologous/allogeneic stem cell transplantation and renal replacement therapy;
10. Known uncontrolled diabetes mellitus, pulmonary fibrosis, interstitial lung disease, acute lung disease or liver failure;
11. Known alcohol and/or drug abuse;
12. Pregnant or lactating women;
13. Trial participants with any coexisting medical conditions or diseases judged by the investigators to be likely to impair the conduct of the trial;
14. No legal capacity/limited capacity.
Where this trial is running
Guangzhou, Gaungdong
- Sun Yat-sen University Cancer Center — Guangzhou, Gaungdong, China (Recruiting)
Study contacts
- Study coordinator: Ying Cheng
- Email: chengy02@fineimmu.com
- Phone: 86-02031605836
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.