None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : The cell therapy is named "Ovarian Cancer Tumor-Infiltrating Lymphocyte Cell Therapy [CHA-TIL]". Participants will be assigned to a single arm without randomizati
Sponsors
Bundang CHA General Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female, aged 20-75 years. 2. Recurrent ovarian cancer. 3. Provided written informed consent after understanding the purpose, methods, and potential benefits of the study. 4. Subjects with a histologic or cytologic diagnosis of epithelial ovarian cancer. - Histology: high-grade serous carcinoma 5. At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors(RECIST) criteria. 6. Presence of a tumor lesion = 2 x 2 cm that can be obtained by biopsy or surgery. 7. Adequate bone marrow function as defined by: - Absolute neutrophil count (ANC) = 1.0 x 10^9/L - Hemoglobin (Hb) = 8.0 g/dL - Platelet count = 75 x 10^9/L 8. Adequate liver function as defined by: - Albumin = 2.8 g/dL - Bilirubin = 2.5 mg/dL - Aspartate Aminotransferase(AST)/Alanine Aminotransferase(ALT) = 3 x upper limit of normal (ULN), Alkaline Phosphatase(ALP) = 5 x ULN 9. Normal coagulation function with Prothrombin Time/activated Partial Thromboplastin Time(PT/aPTT) = 1.5 x ULN. 10. Adequate renal function defined as serum creatinine 45 mL/min calculated by the Cockcroft and Gault formula. 11. Screening blood pressure = 150/90 mmHg, and if taking antihypertensive medications, blood pressure (BP) should be adequately controlled. 12. Eastern Cooperative Oncology Group performance status (ECOG-PS) of 2 or less. 13. For females of childbearing potential, a negative pregnancy test on urine screening. 14. No evidence of infection on blood tests within 6 months. 15. No prior history of receiving other immunotherapies. 16. Provided written informed consent after understanding the purpose, methods, and potential benefits of the study. 17. Willing and able to comply with all aspects of the study protocol.
Exclusion criteria
Exclusion criteria: 1. Individuals with severe cardiopulmonary dysfunction as determined by the Principal Investigator. 2. Individuals with immunodeficiency or autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, or juvenile-onset insulin-dependent diabetes mellitus) that may be exacerbated by immunotherapy. 3. Individuals who are Human Immunodeficiency Virus(HIV) positive. 4. Patients with chronic active hepatitis B or C who are not receiving antiviral treatment: Hepatitis B Virus Polymerase Chain Reaction (HBV PCR) quantification or Hepatitis C Virus Polymerase Chain Reaction (HCV PCR) quantification titer > 20 IU/mL. 5. Individuals with a history of severe allergies. 6. Individuals with uncontrolled hypertension or diabetes. 7. Females of childbearing potential who are pregnant or breastfeeding or unable to use accepted contraception (dual contraception, oral or non-oral hormonal contraception, intrauterine device, and spermicide) for the duration of the study. 8. Individuals with any serious medical or psychiatric condition that, in the opinion of the investigator, would make them unsuitable for the study. 9. Individuals with a history of significant non-cancer-related bleeding disorders. 10. Individuals who have participated in another clinical trial within 4 weeks prior to the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity;Objective response rate;Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy | — |
Countries
Korea, Republic of
Contacts
Public ContactMOON YONG WHA
Bundang CHA General Hospital
Outcome results
None listed