Actively Recruiting
A Phase 2, Multicenter Randomized Controlled Open-label Study of Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer
Led by Grit Biotechnology · Updated on 2026-04-15
83
Participants Needed
24
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Autologous Tumor Infiltrating Lymphocytes (GT101 injection) compared with Gemcitabine in women with recurrent or metastatic cervical cancer. This Phase II study is conducted at multiple centers and involves random assignment to one of two treatment groups. It aims to provide important information about these treatments for patients who have already received prior systemic therapy for this cancer. Participants will receive either GT101 injection, a biological treatment derived from the patient's own tumor cells, or Gemcitabine injection, a chemotherapy drug. The study is open-label, meaning both the participants and researchers know which treatment is given. Treatments are administered according to the study protocol and monitored for effects over time. During the study, women will undergo regular assessments to evaluate disease progression, treatment response, and safety. This includes imaging scans measured by RECIST 1.1 criteria and monitoring for side effects using standardized criteria. The main outcome measured is progression-free survival over three years, along with duration of response and treatment-related adverse events. Participants will be followed for up to three years to track these outcomes.
CONDITIONS
Brief Title
Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand study requirements and provide written informed consent
- Female patients aged 18 to 70 years at the time of consent
- Confirmed diagnosis of unresectable recurrent or metastatic cervical carcinoma with at least one prior systemic therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival time of at least 12 weeks
- Adequate normal organ and marrow function
- Confirmed disease progression by imaging since last treatment before tumor resection
- Measurable disease by RECIST 1.1 criteria in addition to the resected lesion
You will not qualify if you...
- Uncontrollable tumor-related pain or unstable pain management
- Psychiatric disorders or substance abuse including alcohol or drugs
- Pregnant or breastfeeding women, or those planning pregnancy within 1 year of cell infusion
- Participation in other clinical trials within 4 weeks prior to screening or planning concurrent trial participation
- Any other medical condition deemed unsuitable by the investigator for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of treatment as per protocol until disease progression or discontinuation
Participants receive either GT101 injection or Gemcitabine injection to treat cervical cancer.
Visit schedule according to treatment administration protocol
Duration - Up to 3 years
Participants are monitored for treatment response and adverse events after treatment ends.
Regular visits for up to 3 years post-treatment
Trial Site Locations
Total: 24 locations
1
The Fifth Medical Center of the General Hospital of the People's Liberation Army of China
Beijing, Beijing Municipality, China, 222002
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2
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
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3
Chinese Academy of Medical Sciences Cancer Hospital Shenzhen Hospital
Shenzhen, Guangdong, China, 518172
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4
Guangxi Medical University Affiliated Cancer Hospital
Guilin, Guangxi, China, 530021
Actively Recruiting
5
Harbin Medical University Affiliated Cancer Hospital
Ha’erbin, Heilongjjiang, China, 150081
Actively Recruiting
6
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China, 450052
Actively Recruiting
7
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
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8
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
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9
Xiangya Second Hospital of Central South University
Changsha, Hunan, China, 410012
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10
Southeast University Affiliated Zhongda Hospital
Nanjing, Jiangsu, China, 210009
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11
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China, 330006
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12
Affiliated Zhongshan Hospital Dalian University
Dalian, Liaoning, China, 116001
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13
Dalian Medical University First Affiliated Hospital
Dalian, Liaoning, China, 116001
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14
Shandong First Medical University Affiliated Cancer Hospital
Jinan, Shandong, China, 250117
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15
Jining First People's Hospital
Jining, Shandong, China, 272002
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16
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
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17
Fudan University Affiliated Obstetrics and Gynecology Hospital
Shanghai, Shanghai Municipality, China, 214432
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18
Shanxi Cancer Hospital
Taiyuan, Shanxi, China, 030013
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19
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China, 710061
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20
Sichuan University West China Second Hospital
Chengdu, Sichuan, China, 610044
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21
Yibin Second People's Hospital
Yibin, Sichuan, China, 644002
Actively Recruiting
22
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China, 300181
Actively Recruiting
23
Yun Cancer Hospital
Kunming, Yunnan, China, 650118
Actively Recruiting
24
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310005
Actively Recruiting
Research Team
X
XiaoHua Wu, PHD
J
Jing Wang, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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