Experimental t cell therapy targets sarcoma in small early trial
NCT ID NCT03462316
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tested a personalized cell therapy for people with advanced bone or soft tissue sarcoma that had stopped responding to standard treatment. The therapy uses the patient's own immune cells, modified to better recognize and attack cancer cells carrying a specific marker called NY-ESO-1. Only 2 participants were enrolled, and the main goal was to check safety and find the right dose.
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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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2 people
The number who actually took part.
- Started
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May 2018
- Finished
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Apr 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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14 to 70 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 an informed consent before undertaking any trial-related activities; 2. Aged 14 to 70 years old; 3. Patients withbone and soft tissue sarcoma in stage IV by licensed pathologist; 4. First-line treatment failed advanced patients. 5. With measurable lesions, the product of the two maximum vertical diameters should not be less than 5mm\*5mm 6. Meet the two screening indicators: HLA-A\*0201+, NYESO-1+(≥25% by immunohistochemistry); 7. Eastern Cooperative Oncology Group score 0-1; life expectancy is longer than 3 months; 8. The patient did not receive anti-tumor therapy within 4 weeks before enrollment; 9. A brain metastasis patient in a stable condition for one month after anti-tumor therapy can be included; 10. Left ventricular ejection fraction≥50%; 11. Lab test results meet the following requirements: white blood cell count≥3.0×10\^9/L; absolute neutrophil count≥1.5 ×10\^9/L (No human granulocyte colony stimulating factor support); absolute lymphocyte count≥0.7×10\^9/L;blood platelet≥75 ×10\^9/L; Hemoglobin≥10g/dL (No transfusion in the last 14 days); Prothrombin time or International normalized rate ≤1.5×normal upper limit, except taking anticoagulant therapy; thrombin time≤1.5×normal upper limit, except taking anticoagulant therapy; Serum creatinine: 1.5mg /dL (or 132.6 microns /L);a 24-hour creatinine clearance rate≥60mL/ min; Aspartate transaminase / serum glutamic oxaloacetic transaminase≤2.5 ×upper limit of normal; Alanine aminotransferase/ serum glutamate pyruvate transaminase≤2.5 ×upper limit of normal; total bilirubin≤1.5×upper limit of normal. In the case of liver metastasis, glutamate transaminase and glutamate alanine transaminase should be less than 5 x ULN 12. Women of child-bearing age who have not undergone sterilization before menopause must agree to use effective contraceptive measures at least 30 days from the start of the study treatment to the last drug use, and serum pregnancy test is negative 14 days before the first treatment. 13. Men who have not received sterilization must agree to use effective contraception from the start of the study until at least 90 days after the last study medication is administered. 14. During the whole test period, the subjects can regularly go to the enrolled research institutions for relevant detection, evaluation and management. Exclusion Criteria: 1. other types of tumors; If the patient has a previous history of malignant tumor, the disease-free time of the patient needs \> for 5 years. 2. received major surgery, conventional chemotherapy, large-area radiotherapy, immune therapy or any biological anti-tumor therapy within 4 weeks before enrollment; 3. allergic to ingredients in this trial; 4. common terminology criteria for adverse events not return to under 2 level from previous surgery or treatment-related adverse reactions; 5. poorly managed hypertension (systolic blood pressure \>160 mmHg and / or diastolic blood pressure \> 90 mmHg) or clinically serious (for example, active) cerebrovascular diseases such as cerebrovascular incident (within 6 months prior to signing the informed consent), myocardial infarction (within 6 months prior to signing the informed consent), unstable angina, grade II or above heart failure according to New York Heart Association Grading Congestive, or severe arrhythmia can not be controlled by medication or has a potential impact on the study; with consecutive three times of obvious abnormality on electrocardiogram or average QT corrected interval ≥450 millisecond; 6. combined with other serious organic and mental disorders; 7. serious or active bacteria, viral or fungal infections that require systemic treatment; 8. with autoimmune diseases: such as a history of inflammatory bowel disease or other autoimmune diseases determined by the investigator as unsuitable for the study (e.g. systemic lupus erythematosus,vasculitis, invasive pulmonary disease); 9. within 4 weeks prior the infusion, received chronic systemic steroid cortisone, hydroxyurea, immunomodulatory treatment (for example: Interleukin 2, alpha or gamma interferon, granulocyte colony stimulating factor, mammalian target of rapamycin inhibitors, cyclosporine, Thymosin etc); 10. with organ transplantation, autologous/allogeneic stem cell transplantation and renal replacement therapy; 11. with uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or liver failure; 12. alcohol and / or drug abuse; 13. pregnant or lactating women; 14. with any medical condition or disease determined by the investigators that may be detrimental to this trial; 15. without legal capacity / limited behavior. 16. receive any other gene therapy products before study
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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.
Contacts and locations
Locations
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Sun Yat-Sen Univerisity
Guangzhou, Guangdong, 510000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could a massive tissue bank unlock sarcoma's secrets?