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NCT06241781RecruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 15 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
83 (estimated)
First submitted
28 Jan 2024
Start date
2 Apr 2024
Primary completion date
31 Jan 2027
Lead sponsor
Grit Biotechnology
NCT number
NCT06241781

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 83
  • From 2 Apr 2024 to the primary completion date, 31 Jan 2027
  • 24 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;
  • 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;

Other illness

  • 2.Patients who have psychiatric disorders, alcohol, drug or substance abuse;
  • 5.Any other conditions that would make the patient unsuitable candidate for the study at the discretion of the investigator.

Other

  • 3.Women who are pregnant or breastfeeding, or planning to become pregnant within 1 year after cell infusion;

Who the study is looking for

  • 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).

Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (24)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Fifth Medical Center of the General Hospital of the People's Liberation Army of China
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BeijingChinaRecruiting
Xiangya Second Hospital of Central South University
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ChangshaChinaRecruiting
Sichuan University West China Second Hospital
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ChengduChinaRecruiting
Affiliated Zhongshan Hospital Dalian University
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DalianChinaRecruiting
Dalian Medical University First Affiliated Hospital
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DalianChinaRecruiting
Fujian Cancer Hospital
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FuzhouChinaRecruiting
Guangxi Medical University Affiliated Cancer Hospital
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GuilinChinaRecruiting
Harbin Medical University Affiliated Cancer Hospital
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Ha’erbinChinaRecruiting
Zhejiang Cancer Hospital
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HangzhouChinaRecruiting
Shandong First Medical University Affiliated Cancer Hospital
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JinanChinaRecruiting
Jining First People's Hospital
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JiningChinaRecruiting
Yun Cancer Hospital
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KunmingChinaRecruiting
The First Affiliated Hospital of Henan University of Science and Technology
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LuoyangChinaRecruiting
Jiangxi maternal and child health hospital
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NanchangChinaRecruiting
Southeast University Affiliated Zhongda Hospital
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NanjingChinaRecruiting
Fudan University Shanghai Cancer Center
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ShanghaiChinaRecruiting
Fudan University Affiliated Obstetrics and Gynecology Hospital
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ShanghaiChinaRecruiting
Chinese Academy of Medical Sciences Cancer Hospital Shenzhen Hospital
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ShenzhenChinaRecruiting
Shanxi Cancer hospital
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TaiyuanChinaRecruiting
Tianjin Cancer Hospital
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TianjinChinaRecruiting
Hubei Cancer Hospital
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WuhanChinaRecruiting
The First Affiliated Hospital of Xi'an Jiaotong University
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Xi’anChinaRecruiting
Yibin Second People's Hospital
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YibinChinaRecruiting
Henan Cancer Hospital
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ZhengzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.