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

Last updated: February 5, 2025
Sponsor: Grit Biotechnology
Overall Status: Active - Recruiting

Phase

2

Condition

Cervical Cancer

Uterine Disorders

Treatment

Gemcitabine injection

GT101 injection

Clinical Study ID

NCT06241781
GT-CD-CHN-101-02
  • Ages 18-70
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The Patients (or legally authorized representative) Patients (or legallyauthorized representative) must have the ability to understand the requirementsof the study, have provided written informed consent as evidenced by signatureon an informed consent form (ICF) approved by an Institutional ReviewBoard/Independent Ethics Committee (IRB/IEC) ,must have the ability tounderstand the requirements of the study);
  1. The patient must be 18 to 70 years of age at the time of consent;
  1. Must have a confirmed diagnosis of malignancy of their receptive histologies orcytology: unresectable recurrent or metastatic cervical carcinomas andpreviously received≥ 1 prior systemic therapy;
  1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
  1. Expected survival time of ≥ 12 weeks;
  1. Adequate normal organ and marrow function;
  1. Before tumor resection, the confirmatory imaging of disease progress since lasttreatment should be documented.
  • 8.Patients must have measurable disease measured by Response Evaluation Criteria inSolid Tumors (RECIST) 1.1 criteria (in addition to the resected lesion).

Exclusion

Exclusion Criteria:

  • 1.Patients with uncontrollable tumor-related pain as judged by the investigator;participants requiring painkiller must already have had a stable pain managementoptions at the time of study entry; symptomatic lesions suitable for palliativeradiotherapy 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 1year after cell infusion;

  • 4.Participate in other clinical trials within 4 weeks prior to screening, orplanning 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 thestudy at the discretion of the investigator.

Study Design

Total Participants: 83
Treatment Group(s): 2
Primary Treatment: Gemcitabine injection
Phase: 2
Study Start date:
April 02, 2024
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • The Fifth Medical Center of the General Hospital of the People's Liberation Army of China

    Beijing, Beijing 222002
    China

    Active - Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350014
    China

    Active - Recruiting

  • Chinese Academy of Medical Sciences Cancer Hospital Shenzhen Hospital

    Shenzhen, Guangdong 518172
    China

    Active - Recruiting

  • Guangxi Medical University Affiliated Cancer Hospital

    Guilin, Guangxi 530021
    China

    Active - Recruiting

  • Harbin Medical University Affiliated Cancer Hospital

    Ha'erbin, Heilongjjiang 150081
    China

    Active - Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan 450052
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan 450003
    China

    Active - Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei 430079
    China

    Active - Recruiting

  • Xiangya Second Hospital of Central South University

    Changsha, Hunan 410012
    China

    Active - Recruiting

  • Southeast University Affiliated Zhongda Hospital

    Nanjing, Jiangsu 210009
    China

    Active - Recruiting

  • Jiangxi Maternal and Child Health Hospital

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • Affiliated Zhongshan Hospital Dalian University

    Dalian, Liaoning 116001
    China

    Active - Recruiting

  • Dalian Medical University First Affiliated Hospital

    Dalian, Liaoning 116001
    China

    Active - Recruiting

  • Shandong First Medical University Affiliated Cancer Hospital

    Jinan, Shandong 250117
    China

    Active - Recruiting

  • Jining First People's Hospital

    Jining, Shandong 272002
    China

    Active - Recruiting

  • Fudan University Affiliated Obstetrics and Gynecology Hospital

    Shanghai, Shanghai 214432
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi 030013
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shanxi 710061
    China

    Active - Recruiting

  • Sichuan University West China Second Hospital

    Chengdu, Sichuan 610044
    China

    Active - Recruiting

  • Yibin Second People's Hospital

    Yibin, Sichuan 644002
    China

    Active - Recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin 300181
    China

    Active - Recruiting

  • Yun Cancer Hospital

    Kunming, Yunnan 650118
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310005
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.