Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT05620693

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

Led by Shenzhen University General Hospital · Updated on 2022-11-22

20

Participants Needed

1

Research Sites

316 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 70 years, any gender
  • Voluntary participation with signed informed consent
  • Late recurrent or metastatic soft tissue sarcoma confirmed by histopathology
  • Disease progression after first-line treatment
  • Presence of measurable lesions by RECIST 1.1 criteria
  • Tumor tissue positive for NY-ESO-1 expression with HLA-A 02/01 configuration
  • No antibody drug use within 2 weeks before cell therapy
  • ECOG performance status of 0 to 2
  • No contraindications for peripheral blood collection
  • Expected survival longer than 3 months
Not Eligible

You will not qualify if you...

  • History of allergy to any component in cell therapy products
  • Low blood counts: WBC ≤ 1 × 10⁹/L, neutrophils ≤ 0.5 × 10⁹/L, lymphocytes ≤ 0.5 × 10⁹/L, or platelets ≤ 25 × 10⁹/L
  • Abnormal lab tests: total serum bilirubin ≥ 1.5 mg/dl, ALT or AST > 2.5 times upper normal limit, or creatinine ≥ 2.0 mg/dl
  • Severe heart failure (NYHA Grade III or IV) or left ventricular ejection fraction < 50%
  • Abnormal lung function with oxygen saturation < 92% on room air
  • Serious heart conditions within 12 months before enrollment
  • Grade 3 hypertension not controlled by medication
  • History of brain trauma, seizures, serious cerebral ischemia or hemorrhage
  • Autoimmune disease, immunodeficiency, or requiring immunosuppressive treatment
  • Uncontrolled active infections
  • Use of any cell therapy products within 3 months
  • Live vaccine received within 4 weeks before enrollment
  • Positive for HIV, HBV, HCV, TPPA/RPR, or HBV carrier status
  • History of alcohol or drug abuse, or mental illness
  • Participation in other clinical trials within 3 months
  • Pregnancy, lactation, planning pregnancy, or inability to use effective contraception
  • Any other condition the investigator deems unsuitable for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Li Yu

Shenzhen, Guangdong, China, 518000

Actively Recruiting

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Research Team

L

Li Yu, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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