Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients with Recurrent or Metastatic Cervical Cancer
NCT ID: NCT06241781
Last Updated: 2025-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
83 participants
INTERVENTIONAL
2024-04-02
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GT101 injection treatment group
GT101 injection
GT101 injection to treat cervical cancer
Gemcitabine injection treatment group
Gemcitabine injection
Gemcitabine injection to treat cervical cancer
Interventions
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GT101 injection
GT101 injection to treat cervical cancer
Gemcitabine injection
Gemcitabine injection to treat cervical cancer
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 2.Patients who have psychiatric disorders, alcohol, drug or substance abuse;
* 3.Women who are pregnant or breastfeeding, or planning to become pregnant within 1 year after cell infusion;
* 4.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;
* 5.Any other conditions that would make the patient unsuitable candidate for the study at the discretion of the investigator.
18 Years
70 Years
FEMALE
No
Sponsors
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Grit Biotechnology
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GT-CD-CHN-101-02
Identifier Type: -
Identifier Source: org_study_id
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