AdultPhase 2NCT06241781
Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer
A Phase 2 study testing GT101 injection and Gemcitabine injection in people with Adult, run by Grit Biotechnology at 24 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Adult
- What is being tested?
- GT101 injection and Gemcitabine injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 24 sitesChina
- Study dates
- 2 Apr 2024to 31 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jing Wang, PHD contact
24 sites in 1 country
China24 sites, 24 recruiting
- Recruiting
The Fifth Medical Center of the General Hospital of the People's Liberation Army of China
Beijing, Beijing Municipality, 222002
Haifeng Qin, PHD, +86-010-66947114, hifo@263.net
- Recruiting
Xiangya Second Hospital of Central South University
Changsha, Hunan, 410012
Jingjing Wang, PHD, +86 13574841167, 30203021@qq.com
- Recruiting
Sichuan University West China Second Hospital
Chengdu, Sichuan, 610044
Rutie Yin, PHD, +86 18180609015, hx2llwyh@163.com
- Recruiting
Affiliated Zhongshan Hospital Dalian University
Dalian, Liaoning, 116001
Xiang Li, PHD, +86 18018931093, 94207842@qq.com
Ruoyu Wang, PHD, +86 13942875869, Wangruoyu1963@163.com
- Recruiting
Dalian Medical University First Affiliated Hospital
Dalian, Liaoning, 116001
Yi Zhao, PHD, +86 18098876720, zhaoyi0411@126.com
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Qin Xu, PHD, +86 13950419396, 1379423879@qq.com
- Recruiting
Guangxi Medical University Affiliated Cancer Hospital
Guilin, Guangxi, 530021
Jieqing Zhang, PHD, +86 15278015900, 1583825050@qq.com
- Recruiting
Harbin Medical University Affiliated Cancer Hospital
Ha’erbin, Heilongjjiang, 150081
Ge Lou, PHD, +86 15204510777, hydsgcp_fyk@163.com
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005
Hanmei Lou, PHD, +86 15757141349, louhm@zjcc.org.cn
- Recruiting
Shandong First Medical University Affiliated Cancer Hospital
Jinan, Shandong, 250117
Dapeng Li, PHD, +86 15553115531, drldp@126.com
Yuping Sun, PHD, +86 13370582181, 13370582181@163.com
- Recruiting
Jining First People's Hospital
Jining, Shandong, 272002
Jie Li, PHD, +86 13964921790, 13964921790@139.com
- Recruiting
Yun Cancer Hospital
Kunming, Yunnan, 650118
Hongping Zhang, PHD, +86 18725152045, kmzhp@126.com
- Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 450052
Xiaohui Gao, PHD, +86 13838450844, 13838450844@163.com
- Recruiting
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, 330006
Linsheng He, PHD, +86 13979157930, jyfck@163.com
- Recruiting
Southeast University Affiliated Zhongda Hospital
Nanjing, Jiangsu, 210009
Yang Shen, PHD, +86 15366166769, shenyang0924@sina.cn
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xiaohua Wu, PHD, +86-021-64175590, wu.xh@fudan.edu.cn
- Recruiting
Fudan University Affiliated Obstetrics and Gynecology Hospital
Shanghai, Shanghai Municipality, 214432
Yu Kang, PHD, +86 13636328211, kangyu1489@fckyy.org.cn
- Recruiting
Chinese Academy of Medical Sciences Cancer Hospital Shenzhen Hospital
Shenzhen, Guangdong, 518172
Li Sun, PHD, +86 13520594695, xjsunli@sina.com
- Recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030013
Shuqing Wei, PHD, +86 15803411018, Weishuqing1972@163.com
- Recruiting
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300181
Ke Wang, PHD, +86 18622221098, 18622080116@163.com
Hongli Li, PHD, +86 18622221233, hongli@126.com
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Yi Huang, PHD, +86 18971650655, huangygcp@163.com
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
Xiaofeng Yang, PHD, +86 18602900810, dryxf@sina.com
- Recruiting
Yibin Second People's Hospital
Yibin, Sichuan, 644002
Shanbing Wang, PHD, +86 13659037910, 275915691@qq.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Li Wang, PHD, +86 13837196622, clinicaltrial_fuke@163.com
About this study
Official title: 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.
- Conditions
- Adult
- Being tested
- GT101 injection, Gemcitabine injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GT101 injectionBiological
GT101 injection to treat cervical cancer
Gemcitabine injectionDrug
Gemcitabine injection to treat cervical cancer
| Study group | Role | What they receive |
|---|---|---|
| GT101 injection treatment group | Experimental | Not described Receives: Biological: GT101 injection |
| Gemcitabine injection treatment group | Active comparator | Not described Receives: Drug: Gemcitabine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.
Measured: 3 years
Secondary outcomes (2)
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.
Measured: 3 years
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start2 Apr 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdultStudies of the same condition, open and under way.
- More trials run by Grit BiotechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grit Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241781
- Sponsor's protocol ID
- GT-CD-CHN-101-02
- Status last verified
- Apr 2026
- First submitted
- 28 Jan 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter Randomized Controlled Open-label Study of Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer
- ClinicalTrials.gov ID
- NCT06241781
- Acronym / sponsor ID
- GT-CD-CHN-101-02
- Conditions
- Adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Grit BiotechnologyIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GT101 injection treatment group | Experimental | Biological: GT101 injection |
| Gemcitabine injection treatment group | Active comparator | Drug: Gemcitabine injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GT101 injectionGT101 injection to treat cervical cancer | Biological | GT101 injection treatment group |
| Gemcitabine injectionGemcitabine injection to treat cervical cancer | Drug | Gemcitabine injection treatment group |
Primary outcome
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.
2 secondary outcomes
Duration of Response
Time frame: 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jing Wang, PHD contact
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GT101 injection and Gemcitabine injection in people with Adult, run by Grit Biotechnology at 24 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact XiaoHua Wu, PHD (021-64175590, wu.xh@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.