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

Primary Purpose

Advanced Soft-tissue Sarcoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NY-ESO-1 TCR-T
Sponsored by
Shenzhen University General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Soft-tissue Sarcoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged 18-70 (≥ 18, ≤ 70), regardless of gender; Subjects voluntarily participate in the study, and they or their legal guardians sign the Informed Consent Form; Late recurrent or metastatic soft tissue sarcoma confirmed by histopathology; Progress after receiving first-line treatment; According to RECIST 1.1 standard, there are clear assessable lesions; The expression of NY-ESO-1 in tumor tissue was confirmed by immunohistochemical staining; HLA-A configuration is 02/01; Within 2 weeks before cell therapy, no antibody drugs were used; ECOG score is 0-2; The subject has no contraindication for peripheral blood collection; The expected survival period is more than 3 months. Exclusion Criteria: People who have a history of allergy to any component in cell products; 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 ; 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; 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; Pulmonary function is abnormal, and the saturation of blood oxygen under indoor air is less than 92%; Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other serious heart diseases clinically within 12 months before enrollment; Grade 3 hypertension and poor blood pressure control after drug treatment; Have suffered from brain trauma, consciousness disorder, epilepsy, relatively serious cerebral ischemia or cerebral hemorrhage disease in the past; Patients with autoimmune diseases, immunodeficiency or other patients requiring immunosuppressive treatment; There is uncontrolled active infection; Have used any cell therapy products in recent 3 months; Live vaccine inoculation within 4 weeks before enrollment; HIV, HBV, HCV and TPPA/RPR positive persons, and HBV carriers; Subjects have a history of alcohol abuse, drug abuse or mental illness; Subjects have participated in any other clinical research within 3 months before joining this clinical research; 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; The investigator believes that there are other circumstances that are not suitable for the subject to participate in this study.

Sites / Locations

  • Li YuRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

TCR-T treatment group

Outcomes

Primary Outcome Measures

AE/SAE
adverse events/ sever adverse events

Secondary Outcome Measures

ORR
overall response rate

Full Information

First Posted
November 11, 2022
Last Updated
November 17, 2022
Sponsor
Shenzhen University General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05620693
Brief Title
Study of NY-ESO-1 TCR-T in Advanced Soft Tissue Sarcoma
Official Title
Study NY-ESO-1 TCR-T in Advanced Soft Tissue Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2022 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
December 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenzhen University General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Soft-tissue Sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
TCR-T treatment group
Intervention Type
Biological
Intervention Name(s)
NY-ESO-1 TCR-T
Intervention Description
NY-ESO-1 TCR-T treatment
Primary Outcome Measure Information:
Title
AE/SAE
Description
adverse events/ sever adverse events
Time Frame
from infusion to 30 days after infusion
Secondary Outcome Measure Information:
Title
ORR
Description
overall response rate
Time Frame
From admission to the end of follow up, up to 2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-70 (≥ 18, ≤ 70), regardless of gender; Subjects voluntarily participate in the study, and they or their legal guardians sign the Informed Consent Form; Late recurrent or metastatic soft tissue sarcoma confirmed by histopathology; Progress after receiving first-line treatment; According to RECIST 1.1 standard, there are clear assessable lesions; The expression of NY-ESO-1 in tumor tissue was confirmed by immunohistochemical staining; HLA-A configuration is 02/01; Within 2 weeks before cell therapy, no antibody drugs were used; ECOG score is 0-2; The subject has no contraindication for peripheral blood collection; The expected survival period is more than 3 months. Exclusion Criteria: People who have a history of allergy to any component in cell products; 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 ; 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; 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; Pulmonary function is abnormal, and the saturation of blood oxygen under indoor air is less than 92%; Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other serious heart diseases clinically within 12 months before enrollment; Grade 3 hypertension and poor blood pressure control after drug treatment; Have suffered from brain trauma, consciousness disorder, epilepsy, relatively serious cerebral ischemia or cerebral hemorrhage disease in the past; Patients with autoimmune diseases, immunodeficiency or other patients requiring immunosuppressive treatment; There is uncontrolled active infection; Have used any cell therapy products in recent 3 months; Live vaccine inoculation within 4 weeks before enrollment; HIV, HBV, HCV and TPPA/RPR positive persons, and HBV carriers; Subjects have a history of alcohol abuse, drug abuse or mental illness; Subjects have participated in any other clinical research within 3 months before joining this clinical research; 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; The investigator believes that there are other circumstances that are not suitable for the subject to participate in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Yu, Dr
Phone
+8675521839178
Email
liyu@vip.163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Yu, Dr
Organizational Affiliation
Shenzhen University General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Li Yu
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yu
Phone
+8675521839178
Email
liyu_gcp@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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