Engineered immune cells take on Hard-to-Treat cancers
NCT ID NCT06942143
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase trial tests a new cell therapy called Super1 TCR-T in 15 people with advanced solid tumors (sarcoma, lung cancer, or melanoma) that have not responded to first-line treatment. The therapy involves taking a patient's own immune cells, genetically modifying them to better recognize and attack cancer cells, and infusing them back after a short course of chemotherapy. The main goals are to check safety and find the right dose.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Super1 TCR-T cells (genetically modified immune cells)
- What this could lead to
- If successful, this could point toward a new treatment option for certain advanced solid tumors that have not responded to standard therapy.
- What could go wrong
- This is a very early, small Phase 1 trial focused on safety, not effectiveness. The treatment may not shrink tumors or improve survival, and there are risks from the cell infusion and pre-conditioning chemotherapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Gaungdong, 510700, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a Blood-Flow-Blocking drug stall a rare sarcoma?
- Blood test could spot Melanoma's BRAF mutation
- Can a CXCR1/2 blocker boost radiation against cancer that spreads to the brain lining?
- Can a new drug shrink advanced solid tumors?
- Can a coordinated care team reduce severe side effects in older cancer patients?