Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients with Recurrent or Metastatic Cervical Cancer

NCT ID: NCT06241781

Last Updated: 2025-02-07

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-02

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GT101 injection treatment group

Group Type EXPERIMENTAL

GT101 injection

Intervention Type BIOLOGICAL

GT101 injection to treat cervical cancer

Gemcitabine injection treatment group

Group Type ACTIVE_COMPARATOR

Gemcitabine injection

Intervention Type DRUG

Gemcitabine injection to treat cervical cancer

Interventions

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GT101 injection

GT101 injection to treat cervical cancer

Intervention Type BIOLOGICAL

Gemcitabine injection

Gemcitabine injection to treat cervical cancer

Intervention Type DRUG

Eligibility Criteria

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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 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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Grit Biotechnology

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Chinese Academy of Medical Sciences Cancer Hospital Shenzhen Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

Guangxi Medical University Affiliated Cancer Hospital

Guilin, Guangxi, China

Site Status RECRUITING

Harbin Medical University Affiliated Cancer Hospital

Ha’erbin, Heilongjjiang, China

Site Status RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Site Status RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Xiangya Second Hospital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

Southeast University Affiliated Zhongda Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Jiangxi Maternal and Child Health Hospital

Nanchang, Jiangxi, China

Site Status RECRUITING

Affiliated Zhongshan Hospital Dalian University

Dalian, Liaoning, China

Site Status RECRUITING

Dalian Medical University First Affiliated Hospital

Dalian, Liaoning, China

Site Status RECRUITING

Shandong First Medical University Affiliated Cancer Hospital

Jinan, Shandong, China

Site Status RECRUITING

Jining First People's Hospital

Jining, Shandong, China

Site Status RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Fudan University Affiliated Obstetrics and Gynecology Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

Site Status RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Site Status RECRUITING

Sichuan University West China Second Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Yibin Second People's Hospital

Yibin, Sichuan, China

Site Status RECRUITING

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Yun Cancer Hospital

Kunming, Yunnan, China

Site Status RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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XiaoHua Wu, PHD

Role: CONTACT

021-64175590

Jing Wang, PHD

Role: CONTACT

Facility Contacts

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Haifeng Qin, PHD

Role: primary

+86-010-66947114

Qin Xu, PHD

Role: primary

+86 13950419396

Li Sun, PHD

Role: primary

+86 13520594695

Jieqing Zhang, PHD

Role: primary

+86 15278015900

Ge Lou, PHD

Role: primary

+86 15204510777

Xiaohui Gao, PHD

Role: primary

+86 13838450844

Li Wang, PHD

Role: primary

+86 13837196622

Yi Huang, PHD

Role: primary

+86 18971650655

Jingjing Wang, PHD

Role: primary

+86 13574841167

Yang Shen, PHD

Role: primary

+86 15366166769

Linsheng He, PHD

Role: primary

+86 13979157930

Xiang Li, PHD

Role: primary

+86 18018931093

Ruoyu Wang, PHD

Role: backup

+86 13942875869

Yi Zhao, PHD

Role: primary

+86 18098876720

Dapeng Li, PHD

Role: primary

+86 15553115531

Yuping Sun, PHD

Role: backup

+86 13370582181

Jie Li, PHD

Role: primary

+86 13964921790

Xiaohua Wu, PHD

Role: primary

+86-021-64175590

Yu Kang, PHD

Role: primary

+86 13636328211

Shuqing Wei, PHD

Role: primary

+86 15803411018

Xiaofeng Yang, PHD

Role: primary

+86 18602900810

Rutie Yin, PHD

Role: primary

+86 18180609015

Shanbing Wang, PHD

Role: primary

+86 13659037910

Ke Wang, PHD

Role: primary

+86 18622221098

Hongli Li, PHD

Role: backup

+86 18622221233

Hongping Zhang, PHD

Role: primary

+86 18725152045

Hanmei Lou, PHD

Role: primary

+86 15757141349

Other Identifiers

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GT-CD-CHN-101-02

Identifier Type: -

Identifier Source: org_study_id

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