A Clinical Trial to Evaluate the Safety of Autologous Tumor-infiltrating Lymphocytes(TILs) for the Treatment of Recurrent Ovarian Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Evaluation of cytotoxicity of cells against cancer cells
Study Overview
Brief Summary
The objective of this clinical trial is to evaluate the safety of autologous tumor-infiltrating lymphocytes and to investigate their efficacy in recurrent ovarian cancer.
Participants undergo the following process:
There must be a cancerous lesion available for biopsy or surgery, and enhanced tumor-infiltrating lymphocytes are cultured from ovarian cancer tissue collected from the subject.
These are processed into human cells for administration and injected into the subject.
Detailed Description
Administer a fixed dose of CHA-TIL to the subject as a single intravenous infusion and evaluate safety and preliminary efficacy for 6 months.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Recurrent ovarian cancer
- •There is a cancerous lesion that can be removed by biopsy or surgery.
Exclusion Criteria
- •Patient with immunodeficiency or autoimmune diseases that may be exacerbated by immunotherapy
- •Patient deemed unsuitable by the principal investigator
Arms & Interventions
autologous tumor-infiltrating lymphocytes(TILs) for the treatment
Intervention: autologous tumor-infiltrating lymphocytes (Other)
Outcomes
Primary Outcomes
Evaluation of cytotoxicity of cells against cancer cells
Time Frame: Treatment period- 2 months, follow-up- 4 months after completion of treatment
* Primary cancer cells isolated and cultured from a single cell of the same patient's tumor, or TIL cells cultured from the ovarian cancer cell line OVCAR3, are co-cultured in a CO2 incubator for 20 hours. After 20 hours, the cells are stained with 7AAD, and the cancer cell killing ability is analyzed using a flow cytometer * Measurement of IFN-γ secreted by T cells: CD8+ T cells inhibit tumor cell differentiation and enhance immune function by secreting IFN-γ. After co-culturing target cells and T cells, the pellet is used for cytotoxicity evaluation, and the culture medium is collected to measure the amount of secreted IFN-γ using ELISA. * Microscopic assay: After co-culturing fluorescently labeled primary cancer cells with fluorescently labeled enhanced T cells for 20 hours, the number of viable tumor cells is measured.
Evaluation of toxicity of protocol therapy including lymphodepletion, CHA-TIL, and high dose IL2
Time Frame: Treatment periods 2 months, follow-up 4 months after completion of treatment
* Toxicity evaluation variables subject to analysis include adverse events, clinical laboratory test results (e.g., hematology, coagulation, serum analysis, and urinalysis), physical examination, and vital signs. Clinically significant changes from baseline will be summarized using descriptive statistics. The severity of adverse events will be graded according to CTCAE v5.0 and recorded in the case report form. * The overall frequency of adverse events (number of subjects and percentage), the worst reported severity, and the association with the investigational medicinal product will be recorded for each subject. * Serious adverse events are summarized in a similar manner. A list of deaths, SAEs, and AEs that lead to early termination or withdrawal from the clinical trial will also be provided. * For all AEs, a complete list will be presented including the subject number, clinical trial regimen, severity, severity, actions taken, outcome, association with the clinical trial treatment,
Secondary Outcomes
No secondary outcomes reported
Investigators
Yong Wha Moon
Professor
CHA University