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RecruitingNCT06241781Updated Apr 15, 2026

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

A Phase 2 interventional study of GT101 injection and Gemcitabine injection in Adult, sponsored by Grit Biotechnology. Recruiting at 24 sites in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-15.

Sponsored by Grit Biotechnology · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 6 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
83
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

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.

02

Conditions studied

  • Adult
03

In context

Lead sponsor

Grit Biotechnology is the lead sponsor of 30 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
83 participants (estimated)

Study arms

  • Experimental
    GT101 injection treatment group

    Biological: GT101 injection

  • Active comparator
    Gemcitabine injection treatment group

    Drug: Gemcitabine injection

Interventions

  • BiologicalGT101 injection

    GT101 injection to treat cervical cancer

  • DrugGemcitabine injection

    Gemcitabine injection to treat cervical cancer

06

What researchers measure

Primary outcomes

  1. Progression Free Survival

    Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.

    Time frame: 3 years

Secondary outcomes

  1. Duration of Response

    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.

    Time frame: 3 years

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    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.

    Time frame: 3 years

07

Study locations

24 of 24 sites recruiting
  • The Fifth Medical Center of the General Hospital of the People's Liberation Army of China
    Beijing, Beijing Municipality 222002, China
    • Haifeng Qin, PHD · Contact · hifo@263.net · +86-010-66947114
    Recruiting
  • Fujian Cancer Hospital
    Fuzhou, Fujian 350014, China
    Recruiting
  • Chinese Academy of Medical Sciences Cancer Hospital Shenzhen Hospital
    Shenzhen, Guangdong 518172, China
    Recruiting
  • Guangxi Medical University Affiliated Cancer Hospital
    Guilin, Guangxi 530021, China
    Recruiting
  • Harbin Medical University Affiliated Cancer Hospital
    Ha’erbin, Heilongjjiang 150081, China
    Recruiting
  • The First Affiliated Hospital of Henan University of Science and Technology
    Luoyang, Henan 450052, China
    Recruiting
  • Henan Cancer Hospital
    Zhengzhou, Henan 450003, China
    Recruiting
  • Hubei Cancer Hospital
    Wuhan, Hubei 430079, China
    Recruiting
  • Xiangya Second Hospital of Central South University
    Changsha, Hunan 410012, China
    Recruiting
  • Southeast University Affiliated Zhongda Hospital
    Nanjing, Jiangsu 210009, China
    Recruiting
  • Jiangxi Maternal and Child Health Hospital
    Nanchang, Jiangxi 330006, China
    Recruiting
  • Affiliated Zhongshan Hospital Dalian University
    Dalian, Liaoning 116001, China
    Recruiting
  • Dalian Medical University First Affiliated Hospital
    Dalian, Liaoning 116001, China
    Recruiting
  • Shandong First Medical University Affiliated Cancer Hospital
    Jinan, Shandong 250117, China
    Recruiting
  • Jining First People's Hospital
    Jining, Shandong 272002, China
    Recruiting
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai Municipality 200032, China
    Recruiting
  • Fudan University Affiliated Obstetrics and Gynecology Hospital
    Shanghai, Shanghai Municipality 214432, China
    Recruiting
  • Shanxi Cancer Hospital
    Taiyuan, Shanxi 030013, China
    Recruiting
  • The First Affiliated Hospital of Xi'an Jiaotong University
    Xi’an, Shanxi 710061, China
    Recruiting
  • Sichuan University West China Second Hospital
    Chengdu, Sichuan 610044, China
    Recruiting
  • Yibin Second People's Hospital
    Yibin, Sichuan 644002, China
    Recruiting
  • Tianjin Cancer Hospital
    Tianjin, Tianjin Municipality 300181, China
    Recruiting
  • Yun Cancer Hospital
    Kunming, Yunnan 650118, China
    • Hongping Zhang, PHD · Contact · kmzhp@126.com · +86 18725152045
    Recruiting
  • Zhejiang Cancer Hospital
    Hangzhou, Zhejiang 310005, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06241781
Lead sponsor
Grit Biotechnology
Responsible party
Sponsor
First posted
Feb 5, 2024
Start date
Apr 2, 2024
Primary completion
Jan 31, 2027 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Apr 15, 2026

Study contacts

XiaoHua Wu, PHD
Contact
wu.xh@fudan.edu.cn
021-64175590
Jing Wang, PHD
Contact
wangjing0081@126.com

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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