Single center single arm clinical prospective study of NY-ESO-1 TCR-T in the treatment of Chinese patients with NY-ESO-1 positive advanced refractory solid tumors

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-OIC-17011274

Enrollment

Unknown

Registered

2017-05-01

Start date

2017-06-01

Completion date

Unknown

Last updated

2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NY-ESO-1 positive advanced refractory solid tumors

Interventions

1:NY-ESO-1TCR-T

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 18 to 75 years old; 2. Stage IV or locally advanced histologically confirmed solid tumors for which no alternative therapies with proven survival advantage are available; 3. NY-ESO-1 positive malignancy by immunohistochemistry (IHC) utilizing commonly available NY-ESO-1 antibodies; 4. Human leukocyte antigen (HLA)-A*0201 (HLA-A2.1) positivity by molecular subtyping; 5. A minimum of one measurable lesion defined as meeting the criteria for measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST); 6. ECOG<0-2 and expected survival time 3 months or more; 7. without anticancer treatment more than one month; 8. Hematology Index including: Neutrophile granulocyte greater than 1.5×10^9/L; Hemoglobin greater than 10g/dL; Platelet greater than 100×10^9/L; 9. Biochemical index including: Serum bilirubin not greater than 1.5x upper limit of reference range (ULN); ALT or AST not greater than 2.5x ULN; Creatinine clearance no less than 60ml/min; 10. Peripheral venous channel open and no contraindications to separating lymphocytes; 11. Negative pregnancy test for women of childbearing potential, and patients must be willing to practice birth control during the regimen; 12. Provision of informed consent; 13. Be able to follow the research program and follow up process.

Exclusion criteria

Exclusion criteria: 1. Those who now are undering other antitumor drug therapy (including chemotherapy, systemic steroids therapy, surgery, target therapy or immune therapy); 2. Prior malignancy active within the previous 5 years except for locally curable cancers that have been apparently cured, such as basal cell skin cancer or carcinoma in situ of the cervix; 3. Patients with active bacteria or fungal infection; 4. History with pulmonary tuberculosis, and positive tests for HIV, HCV, HBV; 5. uncontrolled angiocardiopathy (heart failure > class II NYHA, heart block >II grade, myocardial infarction, unstable arrhythmia or unstable angina within past 6 months, cerebral infarction within past 3 months); 6. Pregnant or nursing; 7. Psychiatric medicines abuse without withdrawal, or history of psychiatric illness; 8. Patients with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications; 9. Hypersensitivity to investigational drugs or its components.

Design outcomes

Primary

Measure	Time frame
treatment-related adverse events;Objective Response Rate (ORR);	—

Secondary

Measure	Time frame
Progression-free survival(PFS);Overall survival (OS);tumor markers;life quality;Immunological indexes;	—

Countries

China

Contacts

Public ContactBaorui Liu

Nanjing Drum-Tower Hospital

baoruiliu@nju.edu.cn+86 13770621908

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026