Recurrent Ovarian CancerNCT07651124
To Evaluate the Safety of Autologous Tumor-infiltrating Lymphocytes(TILs) for the Treatment of Recurrent Ovarian Cancer
A study testing autologous tumor-infiltrating lymphocytes in people with Recurrent Ovarian Cancer, run by Yong Wha Moon at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Recurrent Ovarian Cancer
- What is being tested?
- autologous tumor-infiltrating lymphocytes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent ovarian cancer
- There is a cancerous lesion that can be removed by biopsy or surgery.
Who cannot join
- Patient with immunodeficiency or autoimmune diseases that may be exacerbated by immunotherapy
- Patient deemed unsuitable by the principal investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Bundang CHA Medical Center
Gyeonggi-do, Bundang-gu, 13520
Miyoung Kim, 82-31-780-5306, a210647@chamc.co.kr
About this study
Official title: 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.
Read the 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.
- Conditions
- Recurrent Ovarian Cancer
- Being tested
- autologous tumor-infiltrating lymphocytes
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous tumor-infiltrating lymphocytesOther
Autologous tumor-infiltrating lymphocytes are cultured from tumor cells collected from the subject and administered as a single intravenous injection to the subject.
| Study group | Role | What they receive |
|---|---|---|
| autologous tumor-infiltrating lymphocytes(TILs) for the treatment | Other | Not described Receives: Other: autologous tumor-infiltrating lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of cytotoxicity of cells against cancer cells
- 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.
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
- 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,
Measured: Treatment periods 2 months, follow-up 4 months after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yong Wha Moon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yong Wha Moon, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651124
- Sponsor's protocol ID
- CHA-TIL
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Safety of Autologous Tumor-infiltrating Lymphocytes(TILs) for the Treatment of Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07651124
- Acronym / sponsor ID
- CHA-TIL
- Conditions
- Recurrent Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Yong Wha MoonUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| autologous tumor-infiltrating lymphocytes(TILs) for the treatment | Other | Other: autologous tumor-infiltrating lymphocytes |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Recurrent ovarian cancer
- There is a cancerous lesion that can be removed by biopsy or surgery.
Key exclusion criteria (2 listed)
- Patient with immunodeficiency or autoimmune diseases that may be exacerbated by immunotherapy
- Patient deemed unsuitable by the principal investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous tumor-infiltrating lymphocytesAutologous tumor-infiltrating lymphocytes are cultured from tumor cells collected from the subject and administered as a single intravenous injection to the subject. | Other | autologous tumor-infiltrating lymphocytes(TILs) for the treatment |
Primary outcome
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,
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autologous tumor-infiltrating lymphocytes in people with Recurrent Ovarian Cancer, run by Yong Wha Moon at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Wha Moon (82-31-780-3436, ymoon@cha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of cytotoxicity of cells against cancer cells (time frame: Treatment period- 2 months, follow-up- 4 months after completion of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.