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

An Open-label, Phase I Clinical Trial of Super1 TCR-T in NY-ESO-1-positive Patients With Advanced Solid Tumors (NCT06942143) is a Phase 1 interventional studying Sarcoma and Lung Cancers, sponsored by Guangzhou FineImmune Biotechnology Co., LTD.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Sarcoma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 15 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Sign willing to sign a consent form 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; - blood count (hemoglobin) at least 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 kidney function (creatinine clearance) at least 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. Who Should NOT Join This Trial: 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; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

BIOLOGICAL

Super1 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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Sun Yat-sen University Cancer Center

Guangzhou, Gaungdong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06942143), the sponsor (Guangzhou FineImmune Biotechnology Co., LTD.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06942143 clinical trial studying?

This study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06942143?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06942143?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06942143. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06942143. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.