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New treatment option for Sarcoma
Official title An Open-label, Phase I Clinical Trial of Super1 TCR-T in NY-ESO-1-positive Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06942143
What this study is testing
What is Super1 TCR-T?
Super1 TCR-T is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sarcoma.
Also referred to as NY-ESO-1 TCR-T.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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) :
You likely can't join if
- Patients who received major surgery, conventional chemotherapy, large area radiotherapy, immunotherapy or biological therapy within 4 weeks before...
- 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...
- 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...
See the full eligibility criteria
- 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;
- 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
- Negative pregnancy tests in women of childbearing potential prior to study treatment; Consent must be given to use effective contraception during treatment.
- During the whole period of the trial, I can regularly visit the enrolled research institutions for relevant testing, evaluation and management.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Gaungdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Gaungdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.