OncoMatch

OncoMatch/Clinical Trials/NCT06942143

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

Is NCT06942143 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Super1 TCR-T for sarcoma.

Phase 1RecruitingGuangzhou FineImmune Biotechnology Co., LTD.NCT06942143Data as of May 2026

Treatment: Super1 TCR-TThis study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation.

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Extracted eligibility criteria

Cancer type

Sarcoma

Melanoma

Biomarker criteria

Required: HLA-A A*02 positive

HLA-A*02 positive

Required: CTAG1B immunohistochemical staining positive rate ≥20% (≥20%)

The positive rate of NYESO-1 immunohistochemical staining was ≥20%.

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: antineoplastic therapy — first-line

Patients with first-line treatment failure

Cannot have received: antineoplastic drugs and treatments

Antineoplastic drugs and treatments were not allowed for 4 weeks before TCR-T cell infusion

Cannot have received: major surgery

Patients who received major surgery...within 4 weeks before entering the trial

Cannot have received: conventional chemotherapy

Patients who received...conventional chemotherapy...within 4 weeks before entering the trial

Cannot have received: large area radiotherapy

Patients who received...large area radiotherapy...within 4 weeks before entering the trial

Cannot have received: immunotherapy

Patients who received...immunotherapy...within 4 weeks before entering the trial

Cannot have received: biological therapy

Patients who received...biological therapy within 4 weeks before entering the trial

Cannot have received: chronic systemic cortisone steroids

Administration of chronic systemic cortisone steroids...within 4 weeks prior to cell therapy.

Cannot have received: hydroxyurea (hydroxyurea)

Administration of...hydroxyurea...within 4 weeks prior to cell therapy.

Cannot have received: immunomodulatory agents (interleukin-2, interferon-α, interferon-γ, GM-CSF, mTOR inhibitors, cyclosporine, thymosin)

Administration of...immunomodulatory agents (e.g., interleukin-2, interferon-α or γ, GM-CSF, mTOR inhibitors, cyclosporine, thymosin, etc.) within 4 weeks prior to cell therapy.

Lab requirements

Blood counts

WBC ≥3.0×10^9/L; ANC ≥1.5×10^9/L; ALC ≥1.0×10^9/L; PLT ≥75×10^9/L; hemoglobin ≥10g/dL (no blood transfusion in the past 7 days); Prothrombin time or INR≤1.5x ULN unless receiving anticoagulant therapy; APTT ≤1.5x ULN unless receiving anticoagulant therapy

Kidney function

24-hour creatinine clearance ≥60mL/min

Liver function

AST/SGOT ≤2.5×ULN; ALT/SGPT ≤2.5×ULN; Total bilirubin (TBIL) ≤1.5×ULN

Cardiac function

Echocardiography showed left ventricular ejection fraction ≥50%

Laboratory test results should at least meet the following specified indicators: WBC ≥3.0×10^9/L; ANC ≥1.5×10^9/L; ALC ≥1.0×10^9/L; PLT ≥75×10^9/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; AST/SGOT ≤2.5×ULN; ALT/SGPT ≤2.5×ULN; Total bilirubin (TBIL) ≤1.5×ULN. Echocardiography showed left ventricular ejection fraction ≥50%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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