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

NCT ID: NCT06942143

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-22
• Study Completion Date: 2027-06-25

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.

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.

Conditions

Sarcoma; Lung Cancers; Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Super1 TCR-T

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

NY-ESO-1 TCR-T

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: collaborator

Guangzhou FineImmune Biotechnology Co., LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Gaungdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ying Cheng

Role: CONTACT

chengy02@fineimmu.com

86-02031605836 ext. 08613535517727

Facility Contacts

Xing Zhang, Professor

Role: primary

zhangxing@sysucc.org.cn

020-87343629

Other Identifiers

FIT002-IIT

Identifier Type: -

Identifier Source: org_study_id