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

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

Study Overview

• Status: Recruiting
• Conditions: Melanoma; Sarcoma; Lung Cancers
• Intervention / Treatment: Biological: Super1 TCR-T

Detailed Description

After the subjects signed the informed consent form, the HLA genotype of the subjects was detected. After the HLA genotype was confirmed as A*02, the tumor tissue was detected by immunohistochemistry. The subjects could proceed to the subsequent clinical trial if the NY-ESO-1 immunohistochemistry was positive. Each subject received only one cell reinfusion.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ying Cheng; Phone Number: 08613535517727 86-02031605836; Email: chengy02@fineimmu.com

Study Locations

• China
  • Gaungdong
    • Guangzhou, Gaungdong, China, 510700
      • Recruiting
      • Sun Yat-Sen University Cancer Center
      • Contact: Xing Zhang, Professor; Phone Number: 020-87343629; Email: zhangxing@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose escalation was performed in a 3+3 design; The Super1 TCR-T dose toxicity test was escalated according to the following dose (positive cells) escalation schedule: Level 1 Level 2 Level 3	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.; Other Names: NY-ESO-1 TCR-T

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DLT	Determining the dose-limiting toxicity (DLT) of Super1 TCR-T adoptive Immunotherapy	Up to 28 Days
MDT	Determining the maximum Tolerated dose (MTD) of Super1 TCR-T adoptive Immunotherapy	Up to 28 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective response rate,defined as the proportion of subjects with a confirmed PR or better best response	One year after cell reinfusion
OS	overall survival，time from subject's treatment to death. Participants with no death recorded at the time of statistical analysis were censored at the time of the last follow-up. In cases of loss to follow-up, data were censored at the date of the last contact with the participant.	One year after cell reinfusion
PFS	progression-free survival ，the time from the subject's treatment to the occurrence of PD or death from any cause, whichever occurred first. If no event (PD or death) occurred, the date of the last response assessment was the censored time for PFS.	One year after cell reinfusion

Collaborators and Investigators

• Sponsor: Guangzhou FineImmune Biotechnology Co., LTD.
• Collaborators: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2025
• Primary Completion (Estimated): April 25, 2027
• Study Completion (Estimated): June 25, 2027

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: April 21, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Immunotherapy; Solid tumor; Cell therapy; NY-ESO-1 TCR-T
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Neoplasms, Connective and Soft Tissue; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Lung Neoplasms; Melanoma; Sarcoma
• Other Study ID Numbers: FIT002-IIT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No