To Evaluate the Safety of Autologous Tumor-infiltrating Lymphocytes(TILs) for the Treatment of Recurrent Ovarian Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: autologous tumor-infiltrating lymphocytes.
- Who it may be relevant to
- Registry conditions: Recurrent Ovarian Cancer. Basic parameters: from 20 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Clinical Trial to Evaluate the Safety of Autologous Tumor-infiltrating Lymphocytes(TILs) for the Treatment of Recurrent Ovarian Cancer
Overview
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.
Interventions
- 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.
Primary outcome measures
- Evaluation of cytotoxicity of cells against cancer cells [Time frame: 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Bundang CHA Medical Center — Gyeonggi-do
Identifiers
NCT: NCT07651124 · CHA-TIL