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

NCT05620693 | Recruiting DMC

• 1 other identifier: HEM-ONCO-022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Soft-tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• AE/SAE

  adverse events/ sever adverse events

  from infusion to 30 days after infusion

Secondary Outcomes (1)

• ORR

  From admission to the end of follow up, up to 2 years.

Study Arms (1)

Treatment group

EXPERIMENTAL

TCR-T treatment group

Biological: NY-ESO-1 TCR-T

Interventions

NY-ESO-1 TCR-T BIOLOGICAL

NY-ESO-1 TCR-T treatment

Treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shenzhen University General Hospital: lead

Study Sites (1)

Li Yu

Shenzhen, Guangdong, 518000, China

RECRUITING

Study Officials

• Li Yu, Dr

  Shenzhen University General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Yu, Dr

CONTACT

+8675521839178; liyu@vip.163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 17, 2022
• Study Start: November 11, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)