Treatment for advanced soft tissue sarcoma using NY-ESO-1 TCR-T cells

Study NY-ESO-1 TCR-T in Advanced Soft Tissue Sarcoma

This study is testing a new treatment using specially designed immune cells to see if it can help people with advanced soft tissue sarcoma who haven't had success with other treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shenzhen University General Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shenzhen, Guangdong)
• Trial ID: NCT05620693 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of NY-ESO-1 TCR-T cell therapy for patients with advanced soft tissue sarcoma who have not responded to first-line treatments. The study focuses on patients with confirmed late recurrent or metastatic soft tissue sarcoma, aiming to target the NY-ESO-1 antigen, which is highly expressed in these tumors. Participants will undergo treatment with engineered T cells designed to recognize and attack cancer cells expressing this antigen. The trial will assess the response to therapy based on established criteria and monitor for any adverse effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with advanced soft tissue sarcoma that has progressed after first-line treatment and who express the NY-ESO-1 antigen.

Not a fit: Patients with certain blood disorders or those who have had allergic reactions to components of the cell products may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced soft tissue sarcoma who have limited treatment choices.

How similar studies have performed: While the approach of using TCR-T cell therapy is promising, the specific application to NY-ESO-1 in soft tissue sarcoma is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Aged 18-70 (≥ 18, ≤ 70), regardless of gender;
2. Subjects voluntarily participate in the study, and they or their legal guardians sign the Informed Consent Form;
3. Late recurrent or metastatic soft tissue sarcoma confirmed by histopathology; Progress after receiving first-line treatment;
4. According to RECIST 1.1 standard, there are clear assessable lesions;
5. The expression of NY-ESO-1 in tumor tissue was confirmed by immunohistochemical staining; HLA-A configuration is 02/01;
6. Within 2 weeks before cell therapy, no antibody drugs were used;
7. ECOG score is 0-2;
8. The subject has no contraindication for peripheral blood collection;
9. The expected survival period is more than 3 months.

Exclusion Criteria:

1. People who have a history of allergy to any component in cell products;
2. The following conditions occur in blood routine examination: WBC ≤ 1 × 109/L, absolute value of neutrophil ANC ≤ 0.5 × 109/L, absolute value of lymphocyte ALC ≤ 0.5 × 109/L , PLT≦25 × 109/L ；
3. The following conditions occur in laboratory testing: including but not limited to, total serum bilirubin ≥ 1.5mg/dl; Serum ALT or AST is more than 2.5 times of the upper limit of normal; Blood creatinine ≥ 2.0mg/dl;
4. According to the NYHA cardiac function grading standard, patients with cardiac insufficiency belong to Grade III or IV; Or left ventricular ejection fraction (LVEF)\<50% by echocardiography;
5. Pulmonary function is abnormal, and the saturation of blood oxygen under indoor air is less than 92%;
6. Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other serious heart diseases clinically within 12 months before enrollment;
7. Grade 3 hypertension and poor blood pressure control after drug treatment;
8. Have suffered from brain trauma, consciousness disorder, epilepsy, relatively serious cerebral ischemia or cerebral hemorrhage disease in the past;
9. Patients with autoimmune diseases, immunodeficiency or other patients requiring immunosuppressive treatment;
10. There is uncontrolled active infection;
11. Have used any cell therapy products in recent 3 months;
12. Live vaccine inoculation within 4 weeks before enrollment;
13. HIV, HBV, HCV and TPPA/RPR positive persons, and HBV carriers;
14. Subjects have a history of alcohol abuse, drug abuse or mental illness;
15. Subjects have participated in any other clinical research within 3 months before joining this clinical research;
16. Female subjects have any of the following conditions: a) are in pregnancy/lactation; Or b) having a pregnancy plan during the trial; Or c) is fertile and unable to take effective contraceptive measures;
17. The investigator believes that there are other circumstances that are not suitable for the subject to participate in this study.

Where this trial is running

Shenzhen, Guangdong

• Li Yu — Shenzhen, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Li Yu, Dr — Shenzhen University General Hospital
• Study coordinator: Li Yu, Dr

Conditions Advanced Soft-tissue Sarcoma