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Trial Title:
Study of NY-ESO-1 TCR-T in Advanced Soft Tissue Sarcoma
NCT ID:
NCT05620693
Condition:
Advanced Soft-tissue Sarcoma
Conditions: Official terms:
Sarcoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
NY-ESO-1 TCR-T
Description:
NY-ESO-1 TCR-T treatment
Arm group label:
Treatment group
Summary:
Soft tissue sarcoma (STS) is a kind of solid tumor with high heterogeneity. There is no
standard second-line treatment plan for patients who have failed first-line treatment.
NY-ESO-1, a cancer testis antigen, is highly expressed in soft tissue tumors and is an
ideal therapeutic target.
Investigators aim to testify the safety and efficacy of NY-ESO-1 TCR-T cell in advanced
soft tissue sarcoma.
Detailed description:
Soft tissue sarcoma (STS) is a kind of solid tumor with high heterogeneity. The treatment
of STS is complex and challenging, and surgery is still the main treatment method at
present. For patients who are inoperable or advanced, medical treatment should be
considered, mainly including chemotherapy and targeted treatment. At present, there is no
standard second-line treatment plan for patients who failed first-line treatment.
NY-ESO-1, a cancer testis antigen, is highly expressed in soft tissue tumors and is an
ideal therapeutic target.
Investigators aim to testify the safety and efficacy of NY-ESO-1 TCR-T cell in advanced
soft tissue sarcoma.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Li Yu
Address:
City:
Shenzhen
Zip:
518000
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Yu
Phone:
+8675521839178
Email:
liyu_gcp@163.com
Start date:
November 11, 2022
Completion date:
December 1, 2028
Lead sponsor:
Agency:
Shenzhen University General Hospital
Agency class:
Other
Source:
Shenzhen University General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05620693
