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

February 5, 2024 updated by: Grit Biotechnology

A Phase 2, Multicenter Randomized Controlled Open-label Study of Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 222002
        • The Fifth Medical Center of the General Hospital of the People's Liberation Army of China
        • Contact:
          • Haifeng Qin, PHD
          • Phone Number: +86-010-66947114
          • Email: hifo@263.net
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Fujian cancer hospital
        • Contact:
    • Guangdong
      • Shenzhen, Guangdong, China, 518172
        • Chinese Academy of Medical Sciences Cancer Hospital Shenzhen Hospital
        • Contact:
    • Guangxi
      • Guilin, Guangxi, China, 530021
        • Guangxi Medical University Affiliated Cancer Hospital
        • Contact:
    • Heilongjjiang
      • Ha'erbin, Heilongjjiang, China, 150081
        • Harbin medical university Affiliated Cancer Hospital
        • Contact:
    • Henan
      • Luoyang, Henan, China, 450052
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
      • Zhengzhou, Henan, China, 450003
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410012
        • Xiangya Second Hospital of Central South University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Southeast University Affiliated Zhongda Hospital
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Jiangxi Maternal and Child Health Hospital
        • Contact:
          • Linsheng He, PHD
          • Phone Number: +86 13979157930
          • Email: jyfck@163.com
    • Liaoning
      • Dalian, Liaoning, China, 116001
        • Affiliated Zhongshan Hospital Dalian University
        • Contact:
        • Contact:
      • Dalian, Liaoning, China, 116001
        • Dalian Medical University First Affiliated Hospital
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250117
        • Shandong First Medical University Affiliated Cancer Hospital
        • Contact:
        • Contact:
          • Dapeng Li, PHD
          • Phone Number: +86 15553115531
          • Email: drldp@126.com
      • Jining, Shandong, China, 272002
        • Jining First People's Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center
        • Contact:
      • Shanghai, Shanghai, China, 214432
        • Fudan University Affiliated Obstetrics and Gynecology Hospital
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Shanxi Cancer hospital
        • Contact:
      • Xi'an, Shanxi, China, 710061
        • The First Affiliated Hospital of Xi'An JiaoTong University
        • Contact:
          • Xiaofeng Yang, PHD
          • Phone Number: +86 18602900810
          • Email: dryxf@sina.com
    • Sichuan
      • Chengdu, Sichuan, China, 610044
        • Sichuan University West China Second Hospital
        • Contact:
      • Yibin, Sichuan, China, 644002
        • Yibin Second People's Hospital
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300181
        • Tianjin Cancer Hospital
        • Contact:
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650118
        • Yun Cancer Hospital
        • Contact:
          • Hongping Zhang, PHD
          • Phone Number: +86 18725152045
          • Email: kmzhp@126.com
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310005
        • Zhejiang Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GT101 injection treatment group
Biological: GT101 injection
GT101 injection to treat cervical cancer
Active Comparator: Gemcitabine injection treatment group
Drug: Gemcitabine injection
Gemcitabine injection to treat cervical cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: 3 years
Objective Response Rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
3 years
Progression Free Survival
Time Frame: 3 years
Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response
Time Frame: 3 years
Defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.
3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: 3 years
Safety will be monitored by incidence, nature, and severity of treatment-emergent adverse events, including adverse drug reactions graded according to CTCAE version 5.0.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grit Biotechnology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 31, 2024

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

January 28, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Actual)

February 5, 2024

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GT-CD-CHN-101-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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