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.
Treatment: Super1 TCR-T — This study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
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
Prior therapy
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.
Check if I qualifyRelated pages