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
1 other identifier
interventional
83
1 country
24
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2024
Typical duration for phase_2
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2024
CompletedFirst Posted
Study publicly available on registry
February 5, 2024
CompletedStudy Start
First participant enrolled
April 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
April 15, 2026
April 1, 2026
2.8 years
January 28, 2024
April 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.
3 years
Secondary Outcomes (2)
Duration of Response
3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
3 years
Study Arms (2)
GT101 injection treatment group
EXPERIMENTALGemcitabine injection treatment group
ACTIVE COMPARATORInterventions
Gemcitabine injection to treat cervical cancer
Eligibility Criteria
You may qualify if:
- \. 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);
- \. The patient must be 18 to 70 years of age at the time of consent;
- \. 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;
- \. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- \. Expected survival time of ≥ 12 weeks;
- \. Adequate normal organ and marrow function;
- \. Before tumor resection, the confirmatory imaging of disease progress since last treatment should be documented.
- Patients must have measurable disease measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria (in addition to the resected lesion).
You may not qualify if:
- Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring painkiller must already have had a stable pain management options at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;
- Patients who have psychiatric disorders, alcohol, drug or substance abuse;
- Women who are pregnant or breastfeeding, or planning to become pregnant within 1 year after cell infusion;
- Participate in other clinical trials within 4 weeks prior to screening, or planning to participate in this study and other clinical trials at the same time;
- Any other conditions that would make the patient unsuitable candidate for the study at the discretion of the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
The Fifth Medical Center of the General Hospital of the People's Liberation Army of China
Beijing, Beijing Municipality, 222002, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Chinese Academy of Medical Sciences Cancer Hospital Shenzhen Hospital
Shenzhen, Guangdong, 518172, China
Guangxi Medical University Affiliated Cancer Hospital
Guilin, Guangxi, 530021, China
Harbin Medical University Affiliated Cancer Hospital
Ha’erbin, Heilongjjiang, 150081, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 450052, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Xiangya Second Hospital of Central South University
Changsha, Hunan, 410012, China
Southeast University Affiliated Zhongda Hospital
Nanjing, Jiangsu, 210009, China
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, 330006, China
Affiliated Zhongshan Hospital Dalian University
Dalian, Liaoning, 116001, China
Dalian Medical University First Affiliated Hospital
Dalian, Liaoning, 116001, China
Shandong First Medical University Affiliated Cancer Hospital
Jinan, Shandong, 250117, China
Jining First People's Hospital
Jining, Shandong, 272002, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Fudan University Affiliated Obstetrics and Gynecology Hospital
Shanghai, Shanghai Municipality, 214432, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030013, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
Sichuan University West China Second Hospital
Chengdu, Sichuan, 610044, China
Yibin Second People's Hospital
Yibin, Sichuan, 644002, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300181, China
Yun Cancer Hospital
Kunming, Yunnan, 650118, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2024
First Posted
February 5, 2024
Study Start
April 2, 2024
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2027
Last Updated
April 15, 2026
Record last verified: 2026-04