A Study of GC203 TIL in Advanced Gynecologic Tumors (10hospital) (NCT05468307) | Clinical Trial Compass
CompletedEarly Phase 1
A Study of GC203 TIL in Advanced Gynecologic Tumors (10hospital)
China26 participantsStarted 2022-03-10
Plain-language summary
This study is to investigate the safety and efficacy on TIL engineered with membrane-binding cytokine (GC203 TIL) for the treatment of patients with advanced gynecologic tumors. Autologous TILs from tumor resections or biopsies are first gene modified (engineered with membrane-binding cytokine) and than expanded before i.v. infusion into the patient after NMA lymphodepletion treatment with cyclophosphamide.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. Age: 18 years to 75 years;
✓. Histologically diagnosed as primary/relapsed/metastasized Gynecological tumors;
✓. Expected life-span more than 3 months;
✓. Karnofsky≥60% or ECOG score 0-2;
✓. Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.
✓. Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated;
✓. At least 1 evaluable tumor lesion;
✓. Hematology and Chemistry（within 7 days prior to enrollment）:
Exclusion criteria
✕. Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;
✕. Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;
✕. Significant cardiovascular anomalies according to any of the following definition: New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrio-ventricular conductive block, etc.
✕. Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;
✕. Severe physical or mental diseases;
✕. Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection);
✕. Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;
✕. History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy;