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Engineered immune cells take on Hard-to-Treat cancers

NCT ID NCT06942143

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Gaungdong, 510700, China

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