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
- Diseases
- Cervical cancer
- 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
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Fifth Medical Center of the General Hospital of the People's Liberation Army of China Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Xiangya Second Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Sichuan University West China Second Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Affiliated Zhongshan Hospital Dalian University Coordinator of this site? Confirm its status | Dalian | China | Recruiting |
| Dalian Medical University First Affiliated Hospital Coordinator of this site? Confirm its status | Dalian | China | Recruiting |
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Guangxi Medical University Affiliated Cancer Hospital Coordinator of this site? Confirm its status | Guilin | China | Recruiting |
| Harbin Medical University Affiliated Cancer Hospital Coordinator of this site? Confirm its status | Ha’erbin | China | Recruiting |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Shandong First Medical University Affiliated Cancer Hospital Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Jining First People's Hospital Coordinator of this site? Confirm its status | Jining | China | Recruiting |
| Yun Cancer Hospital Coordinator of this site? Confirm its status | Kunming | China | Recruiting |
| The First Affiliated Hospital of Henan University of Science and Technology Coordinator of this site? Confirm its status | Luoyang | China | Recruiting |
| Jiangxi maternal and child health hospital Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| Southeast University Affiliated Zhongda Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Fudan University Affiliated Obstetrics and Gynecology Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Chinese Academy of Medical Sciences Cancer Hospital Shenzhen Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
| Shanxi Cancer hospital Coordinator of this site? Confirm its status | Taiyuan | China | Recruiting |
| Tianjin Cancer Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| Hubei Cancer Hospital Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| The First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi’an | China | Recruiting |
| Yibin Second People's Hospital Coordinator of this site? Confirm its status | Yibin | China | Recruiting |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.