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Recruiting Phase 2

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

NCT06241781 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2024-04-02
Last updated
2026-11-09

Condition(s) studied

Recurrent or Metastatic Cervical Cancer

Investigational drug(s) / intervention(s)

GT101 →Gemcitabine injection →IL-2 →

GT101: Infusion

Gemcitabine injection: Injection

IL-2: Injection

Study 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
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * 1\. Voluntarily enroll in the study, sign the informed consent form, and be willing and able to comply with the study protocol. * 2\. Aged ≥18 years and ≤70 years. * 3\. Recurrent or metastatic cervical cancer: have received prior adequate first-line systemic therapy with radiologically confirmed disease progression during or after treatment. * 4\. Have at least one resectable tumor lesion for the manufacture of autologous tumor-infiltrating lymphocytes (TILs). * 5\. Apart from the sampling lesion(s), have at least one measurable lesion per RECIST 1.1. * 6\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * 7\. Expected survival ≥12 weeks. * 8\. Adequate normal organ and bone marrow function. * 9\. Serum human chorionic gonadotropin (HCG) test must be negative within 7 days prior to TIL infusion for women of childbearing potential without surgical sterilization. * 10\. Adverse events from prior therapies must have recovered to Grade ≤1 (per CTCAE 5.0) before tumor sampling. * 11\. Participants entering this study due to disease progression must have radiological documentation of disease progression following the last prior treatment before tumor resection. Exclusion Criteria: * 1\. Spinal cord compression not relieved by surgery and/or radiotherapy is exclusionary. * 2\. Uncontrolled tumor-related pain as judged by the investigator. * 3\. Bleeding events occurring within 3 months prior to screening. * 4\. Arterial or venous thromboembolic events within 6 months prior to screening, such as cerebrovascular accident, deep vein thrombosis (DVT), pulmonary embolism (PE), etc. * 5\. Respiratory diseases that substantially impair pulmonary function. * 6\. History of clinically significant cardiovascular disease. * 7\. Participants with untreated central nervous system (CNS) metastatic lesions at screening. * 8\. Active autoimmune disease requiring systemic corticosteroids or immunosuppressive therapy. * 9\. Malignancies other than the target indication diagnosed within 5 years before screening. * 10\. Refractory/intractable epilepsy, medically uncontrolled pleural effusion, etc. * 11\. Infectious diseases within 1 year prior to screening. * 12\. Use of anti-angiogenic agents within 4 weeks before sampling. * 13\. Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation. * 14\. Systemic anti-tumor therapy administered within 4 weeks prior to lymphodepleting chemotherapy. * 15\. Prior receipt of genetically modified or edited cellular therapy products. * 16\. History of allergic reaction to any component of the investigational agents to be used in this study. * 17\. Known psychiatric disorders, alcohol abuse, illicit drug use, or substance abuse. * 18\. Prior immunotherapy associated with Grade ≥3 immune-related adverse events (irAEs) that failed to recover to CTCAE Grade 1 or lower within 28 days. * 19\. Pregnant or lactating women, or women planning pregnancy, gestation or lactation within 1 year after cell infusion. * 20\. Receipt of other investigational medicinal products within 4 weeks prior to randomization, or plan to receive other investigational medicinal products during the study. * 21\. Other conditions judged unsuitable for enrollment by the investigator.

Primary outcome measure(s)

  • Progression Free Survival (PFS) (per RECIST V.1.1) by IRC assessment — Up to 2 years post infusion
    Defined as time from first study treatment until disease progression per Response Evaluation Criteria in Solid Tumors \[RECIST Version 1.1\] as assessed by the Independent Review Committee (IRC) or death from any cause, whichever occurs first.

Trial sites (38)

FacilityCityRegionStatus
Beijing Obstetrics and Gynecology Hospital, Capital Medical University Beijing Beijing Municipality Recruiting
Peking University Third Hospital Beijing Beijing Municipality Recruiting
The Fifth Medical Center of the General Hospital of the People's Liberation Army of China Beijing Beijing Municipality Not Yet Recruiting
Army Medical Center of PLA Chongqing Chongqing Municipality Recruiting
Fujian Cancer Hospital Fuzhou Fujian Recruiting
Gansu Provincial Cancer Hospital Lanzhou Gansu Recruiting
Gansu Provincial Maternity and Child-care Hospital Lanzhou Gansu Recruiting
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting
Chinese Academy of Medical Sciences Cancer Hospital Shenzhen Hospital Shenzhen Guangdong Recruiting
Guangxi Medical University Affiliated Cancer Hospital Guilin Guangxi Recruiting
Harbin Medical University Affiliated Cancer Hospital Ha’erbin Heilongjjiang Recruiting
The First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan Recruiting
Henan Cancer Hospital Zhengzhou Henan Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei Recruiting
Zhongnan Hospital of Wuhan University Wuhan Hubei Recruiting
Hubei Cancer Hospital Wuhan Hubei Not Yet Recruiting
Xiangya Second Hospital of Central South University Changsha Hunan Not Yet Recruiting
Hunan Cancer Hospital Changsha Hunan Recruiting
Southeast University Affiliated Zhongda Hospital Nanjing Jiangsu Not Yet Recruiting
Jiangxi Maternal and Child Health Hospital Nanchang Jiangxi Recruiting
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi Recruiting
Affiliated Zhongshan Hospital Dalian University Dalian Liaoning Recruiting
Dalian Medical University First Affiliated Hospital Dalian Liaoning Not Yet Recruiting
Shengjing Hospital of China Medical University Shenyang Liaoning Recruiting
Liaoning Cancer Hospital Shenyang Liaoning Recruiting
Qilu Hospital of Shandong University Jinan Shandong Recruiting
Shandong First Medical University Affiliated Cancer Hospital Jinan Shandong Not Yet Recruiting
Jining First People's Hospital Jining Shandong Not Yet Recruiting
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting
Fudan University Affiliated Obstetrics and Gynecology Hospital Shanghai Shanghai Municipality Recruiting
Shanxi Cancer Hospital Taiyuan Shanxi Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University Xi’an Shanxi Recruiting
West China Hospital, Sichuan University Chengdu Sichuan Recruiting
Sichuan University West China Second Hospital Chengdu Sichuan Recruiting
Yibin Second People's Hospital Yibin Sichuan Recruiting
Tianjin Cancer Hospital Tianjin Tianjin Municipality Recruiting
Yunnan Cancer Hospital Kunming Yunnan Recruiting
Zhejiang Cancer Hospital Hangzhou Zhejiang Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06241781 on ClinicalTrials.gov ↗ ← All trials in China