To Evaluate the Safety of Autologous Tumor-infiltrating Lymphocytes(TILs) for the Treatment of Recurrent Ovarian Cancer

June 15, 2026 updated by: Yong Wha Moon

A Clinical Trial to Evaluate the Safety of Autologous Tumor-infiltrating Lymphocytes(TILs) for the Treatment of Recurrent Ovarian Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
    • Bundang-gu
      • Gyeonggi-do, Bundang-gu, South Korea, 13520
        • Recruiting
        • Bundang CHA Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: autologous tumor-infiltrating lymphocytes(TILs) for the treatment
Other: autologous tumor-infiltrating lymphocytes
Autologous tumor-infiltrating lymphocytes are cultured from tumor cells collected from the subject and administered as a single intravenous injection to the subject.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Treatment period- 2 months, follow-up- 4 months after completion of treatment
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,
Treatment periods 2 months, follow-up 4 months after completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yong Wha Moon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

June 10, 2026

First Submitted That Met QC Criteria

June 15, 2026

First Posted (Actual)

June 16, 2026

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHA-TIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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