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Recruiting NCT07651124

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

No phase Interventional 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 →
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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗