RecruitingPhase 2NCT06241781

Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer

A Phase 2, Multicenter Randomized Controlled Open-label Study of Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer

Sponsor

Grit Biotechnology

Enrollment

83 participants

Start Date

Apr 2, 2024

Study Type

INTERVENTIONAL

Conditions

Adult

Summary

This is a Phase II, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of Autologous Tumor Infiltrating Lymphocytes (GT101 injection) compared with Gemcitabine in participants with recurrent or metastatic cervical cancer.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment called GT101 — a therapy made from the patient's own tumor-infiltrating lymphocytes (TIL), which are immune cells extracted from a tumor, multiplied in the lab, and then infused back into the patient — for women with recurrent or metastatic cervical cancer that has stopped responding to other treatments. **You may be eligible if...** - You are a woman between 18 and 70 years old - You have confirmed recurrent or metastatic cervical cancer - You have received at least one prior systemic therapy that has stopped working - Your general health status is good (ECOG 0 or 1) - Your life expectancy is at least 12 weeks - You have measurable disease on imaging - Your organs and bone marrow are functioning adequately **You may NOT be eligible if...** - You have uncontrolled cancer-related pain - You have other conditions that make it unsafe to participate, as determined by your doctor - You do not have measurable disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALGT101 injection

GT101 injection to treat cervical cancer

DRUGGemcitabine injection

Gemcitabine injection to treat cervical cancer

Locations(24)

The Fifth Medical Center of the General Hospital of the People's Liberation Army of China

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Chinese Academy of Medical Sciences Cancer Hospital Shenzhen Hospital

Shenzhen, Guangdong, China

Guangxi Medical University Affiliated Cancer Hospital

Guilin, Guangxi, China

Harbin Medical University Affiliated Cancer Hospital

Ha’erbin, Heilongjjiang, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Xiangya Second Hospital of Central South University

Changsha, Hunan, China

Southeast University Affiliated Zhongda Hospital

Nanjing, Jiangsu, China

Jiangxi Maternal and Child Health Hospital

Nanchang, Jiangxi, China

Affiliated Zhongshan Hospital Dalian University

Dalian, Liaoning, China

Dalian Medical University First Affiliated Hospital

Dalian, Liaoning, China

Shandong First Medical University Affiliated Cancer Hospital

Jinan, Shandong, China

Jining First People's Hospital

Jining, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Fudan University Affiliated Obstetrics and Gynecology Hospital

Shanghai, Shanghai Municipality, China

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Sichuan University West China Second Hospital

Chengdu, Sichuan, China

Yibin Second People's Hospital

Yibin, Sichuan, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Yun Cancer Hospital

Kunming, Yunnan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06241781

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