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 (Jun 2026). This Phase 1 trial studies Super1 TCR-T for sarcoma.

Phase 1RecruitingGuangzhou FineImmune Biotechnology Co., LTD.NCT06942143Data as of Jun 2026Location: China

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

Treatments studied

Other

Super1 TCR-T

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)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT06942143 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior antineoplastic drugs and treatments, major surgery, conventional chemotherapy disqualifies patients from enrollment.

Does this trial require HLA-A?

Yes, HLA-A A*02 positive is a required biomarker for enrollment.

Does this trial require CTAG1B?

Yes, CTAG1B immunohistochemical staining positive rate ≥20% is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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