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

Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 1\. The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) ,must have the ability to understand the requirements of the study);

• 2\. The patient must be 18 to 70 years of age at the time of consent;

• 3\. Must have a confirmed diagnosis of malignancy of their receptive histologies or cytology: unresectable recurrent or metastatic cervical carcinomas and previously received≥ 1 prior systemic therapy;

• 4\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;

• 5\. Expected survival time of ≥ 12 weeks;

• 6\. Adequate normal organ and marrow function;

• 7\. Before tumor resection, the confirmatory imaging of disease progress since last treatment should be documented.

• 8.Patients must have measurable disease measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria (in addition to the resected lesion).

Locations
Other Locations
China
The Fifth Medical Center of the General Hospital of the People's Liberation Army of China
RECRUITING
Beijing
Xiangya Second Hospital of Central South University
RECRUITING
Changsha
Sichuan University West China Second Hospital
RECRUITING
Chengdu
Affiliated Zhongshan Hospital Dalian University
RECRUITING
Dalian
Dalian Medical University First Affiliated Hospital
RECRUITING
Dalian
Fujian Cancer Hospital
RECRUITING
Fuzhou
Guangxi Medical University Affiliated Cancer Hospital
RECRUITING
Guilin
Harbin Medical University Affiliated Cancer Hospital
RECRUITING
Ha’erbin
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Shandong First Medical University Affiliated Cancer Hospital
RECRUITING
Jinan
Jining First People's Hospital
RECRUITING
Jining
Yun Cancer Hospital
RECRUITING
Kunming
The First Affiliated Hospital of Henan University of Science and Technology
RECRUITING
Luoyang
Jiangxi Maternal and Child Health Hospital
RECRUITING
Nanchang
Southeast University Affiliated Zhongda Hospital
RECRUITING
Nanjing
Fudan University Affiliated Obstetrics and Gynecology Hospital
RECRUITING
Shanghai
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Chinese Academy of Medical Sciences Cancer Hospital Shenzhen Hospital
RECRUITING
Shenzhen
Shanxi Cancer Hospital
RECRUITING
Taiyuan
Tianjin Cancer Hospital
RECRUITING
Tianjin
Hubei Cancer Hospital
RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi’an
Yibin Second People's Hospital
RECRUITING
Yibin
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
XiaoHua Wu, PHD
wu.xh@fudan.edu.cn
021-64175590
Backup
Jing Wang, PHD
wangjing0081@126.com
Time Frame
Start Date: 2024-04-02
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 83
Treatments
Experimental: GT101 injection treatment group
Active_comparator: Gemcitabine injection treatment group
Related Therapeutic Areas
Sponsors
Leads: Grit Biotechnology

This content was sourced from clinicaltrials.gov

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