Trial Title:
Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer
NCT ID:
NCT06241781
Condition:
Adult
Conditions: Official terms:
Uterine Cervical Neoplasms
Gemcitabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
GT101 injection
Description:
GT101 injection to treat cervical cancer
Arm group label:
GT101 injection treatment group
Intervention type:
Drug
Intervention name:
Gemcitabine injection
Description:
Gemcitabine injection to treat cervical cancer
Arm group label:
Gemcitabine injection treatment group
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
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 lines of 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:
- 1.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;
- 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Fifth Medical Center of the General Hospital of the People's Liberation Army of China
Address:
City:
Beijing
Zip:
222002
Country:
China
Status:
Recruiting
Contact:
Last name:
Haifeng Qin, PHD
Phone:
+86-010-66947114
Email:
hifo@263.net
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Recruiting
Contact:
Last name:
Qin Xu, PHD
Phone:
+86 13950419396
Email:
1379423879@qq.com
Facility:
Name:
Chinese Academy of Medical Sciences Cancer Hospital Shenzhen Hospital
Address:
City:
Shenzhen
Zip:
518172
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Sun, PHD
Phone:
+86 13520594695
Email:
xjsunli@sina.com
Facility:
Name:
Guangxi Medical University Affiliated Cancer Hospital
Address:
City:
Guilin
Zip:
530021
Country:
China
Status:
Recruiting
Contact:
Last name:
Jieqing Zhang, PHD
Phone:
+86 15278015900
Email:
1583825050@qq.com
Facility:
Name:
Harbin Medical University Affiliated Cancer Hospital
Address:
City:
Ha'erbin
Zip:
150081
Country:
China
Status:
Recruiting
Contact:
Last name:
Ge Lou, PHD
Phone:
+86 15204510777
Email:
hydsgcp_fyk@163.com
Facility:
Name:
The First Affiliated Hospital of Henan University of Science and Technology
Address:
City:
Luoyang
Zip:
450052
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaohui Gao, PHD
Phone:
+86 13838450844
Email:
13838450844@163.com
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Wang, PHD
Phone:
+86 13837196622
Email:
clinicaltrial_fuke@163.com
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Recruiting
Contact:
Last name:
Yi Huang, PHD
Phone:
+86 18971650655
Email:
huangygcp@163.com
Facility:
Name:
Xiangya Second Hospital of Central South University
Address:
City:
Changsha
Zip:
410012
Country:
China
Status:
Recruiting
Contact:
Last name:
Jingjing Wang, PHD
Phone:
+86 13574841167
Email:
30203021@qq.com
Facility:
Name:
Southeast University Affiliated Zhongda Hospital
Address:
City:
Nanjing
Zip:
210009
Country:
China
Status:
Recruiting
Contact:
Last name:
Yang Shen, PHD
Phone:
+86 15366166769
Email:
shenyang0924@sina.cn
Facility:
Name:
Jiangxi Maternal and Child Health Hospital
Address:
City:
Nanchang
Zip:
330006
Country:
China
Status:
Recruiting
Contact:
Last name:
Linsheng He, PHD
Phone:
+86 13979157930
Email:
jyfck@163.com
Facility:
Name:
Affiliated Zhongshan Hospital Dalian University
Address:
City:
Dalian
Zip:
116001
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiang Li, PHD
Phone:
+86 18018931093
Email:
94207842@qq.com
Contact backup:
Last name:
Ruoyu Wang, PHD
Phone:
+86 13942875869
Email:
Wangruoyu1963@163.com
Facility:
Name:
Dalian Medical University First Affiliated Hospital
Address:
City:
Dalian
Zip:
116001
Country:
China
Status:
Recruiting
Contact:
Last name:
Yi Zhao, PHD
Phone:
+86 18098876720
Email:
zhaoyi0411@126.com
Facility:
Name:
Shandong First Medical University Affiliated Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Recruiting
Contact:
Last name:
Dapeng Li, PHD
Phone:
+86 15553115531
Email:
drldp@126.com
Contact backup:
Last name:
Yuping Sun, PHD
Phone:
+86 13370582181
Email:
13370582181@163.com
Facility:
Name:
Jining First People's Hospital
Address:
City:
Jining
Zip:
272002
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Li, PHD
Phone:
+86 13964921790
Email:
13964921790@139.com
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaohua Wu, PHD
Phone:
+86-021-64175590
Email:
wu.xh@fudan.edu.cn
Facility:
Name:
Fudan University Affiliated Obstetrics and Gynecology Hospital
Address:
City:
Shanghai
Zip:
214432
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Kang, PHD
Phone:
+86 13636328211
Email:
kangyu1489@fckyy.org.cn
Facility:
Name:
Shanxi Cancer Hospital
Address:
City:
Taiyuan
Zip:
030013
Country:
China
Status:
Recruiting
Contact:
Last name:
Shuqing Wei, PHD
Phone:
+86 15803411018
Email:
Weishuqing1972@163.com
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaofeng Yang, PHD
Phone:
+86 18602900810
Email:
dryxf@sina.com
Facility:
Name:
Sichuan University West China Second Hospital
Address:
City:
Chengdu
Zip:
610044
Country:
China
Status:
Recruiting
Contact:
Last name:
Rutie Yin, PHD
Phone:
+86 18180609015
Email:
hx2llwyh@163.com
Facility:
Name:
Yibin Second People's Hospital
Address:
City:
Yibin
Zip:
644002
Country:
China
Status:
Recruiting
Contact:
Last name:
Shanbing Wang, PHD
Phone:
+86 13659037910
Email:
275915691@qq.com
Facility:
Name:
Tianjin Cancer Hospital
Address:
City:
Tianjin
Zip:
300181
Country:
China
Status:
Recruiting
Contact:
Last name:
Ke Wang, PHD
Phone:
+86 18622221098
Email:
18622080116@163.com
Contact backup:
Last name:
Hongli Li, PHD
Phone:
+86 18622221233
Email:
hongli@126.com
Facility:
Name:
Yun Cancer Hospital
Address:
City:
Kunming
Zip:
650118
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongping Zhang, PHD
Phone:
+86 18725152045
Email:
kmzhp@126.com
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310005
Country:
China
Status:
Recruiting
Contact:
Last name:
Hanmei Lou, PHD
Phone:
+86 15757141349
Email:
louhm@zjcc.org.cn
Start date:
April 2, 2024
Completion date:
January 31, 2027
Lead sponsor:
Agency:
Grit Biotechnology
Agency class:
Industry
Source:
Grit Biotechnology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06241781
