An Open-label, Phase I Clinical Trial of Super1 TCR-T in NY-ESO-1-positive Patients With Advanced Solid Tumors

NCT06942143 | Recruiting Phase 1

• 1 other identifier: FIT002-IIT
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sarcoma; Lung Cancers; Melanoma

Keywords

Cell therapy; Immunotherapy; Solid tumor; NY-ESO-1 TCR-T

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• ORR

  One year after cell reinfusion

• OS

  One year after cell reinfusion

• PFS

  One year after cell reinfusion

Study Arms (1)

Dose escalation was performed in a 3+3 design

EXPERIMENTAL

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

Interventions

Super1 TCR-T BIOLOGICAL

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.

Also known as: NY-ESO-1 TCR-T

Dose escalation was performed in a 3+3 design

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign informed consent before conducting any trial-related activities;
• Age of 18-75 years old, male or female;
• Patients with first-line treatment failure;
• Measurable lesions according to RECIST1.1 criteria.
• 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%.
• ECOG score 0-1;
• The expected survival time is more than 3 months;
• Antineoplastic drugs and treatments were not allowed for 4 weeks before TCR-T cell infusion;
• Echocardiography showed left ventricular ejection fraction ≥50%;
• 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;

You may not qualify if:

• Patients who received major surgery, conventional chemotherapy, large area radiotherapy, immunotherapy or biological therapy within 4 weeks before entering the trial;
• Known to produce allergic reactions to any component of the trial treatment;
• no recovery from previous surgery or treatment-related adverse events to ≤ grade 2 CTCAE;
• 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.
• Combined with other serious organic diseases and mental disorders;
• 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)
• 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).
• 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."
• History of organ transplantation, autologous/allogeneic stem cell transplantation and renal replacement therapy;
• Known uncontrolled diabetes mellitus, pulmonary fibrosis, interstitial lung disease, acute lung disease or liver failure;
• Known alcohol and/or drug abuse;
• Pregnant or lactating women;
• Trial participants with any coexisting medical conditions or diseases judged by the investigators to be likely to impair the conduct of the trial;
• No legal capacity/limited capacity.

Sponsors & Collaborators

• Guangzhou FineImmune Biotechnology Co., LTD.: lead
• Sun Yat-sen University: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Gaungdong, 510700, China

RECRUITING

MeSH Terms

Conditions

Sarcoma; Lung Neoplasms; Melanoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Ying Cheng

CONTACT

86-02031605836; chengy02@fineimmu.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 24, 2025
• Study Start: May 22, 2025
• Primary Completion (Estimated): April 25, 2027
• Study Completion (Estimated): June 25, 2027
• Last Updated: September 3, 2025

Record last verified: 2025-04

Locations

CN (1)