A Phase 2 interventional study of GT101 and Gemcitabine injection in Recurrent or Metastatic Cervical Cancer, sponsored by Grit Biotechnology. Recruiting at 38 sites in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Grit Biotechnology · Phase 2, Interventional, and Treatment
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Among 455 studies in Uterine Cervical Neoplasms with a site in China — 205 open to participants now, 240 under way, 35 of them phase 3. Uterine Cervical Neoplasms · China.
Among the 455 studies in Uterine Cervical Neoplasms with a site in China, this one is the 163rd largest by planned enrollment of the 360 interventional ones that give a count, is one of 61 that started in 2024, is one of 137 in phase 2, reaches primary completion later than 145 of the 239 other live ones, and was the 326th registered.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
Browse Uterine Cervical Neoplasms studies →205 of the 455 studies in Uterine Cervical Neoplasms with a site in China are open now. Recruiting first, the newest first:
Tianjin Medical University Cancer Institute and Hospital · Sites in China
Ages 17–75 · Women only
Catherin Zhang · Sites in China
Ages 18–75 · Women only
The First Affiliated Hospital with Nanjing Medical University · Sites in China
Ages 18–80 · Women only
Manni Huang · Sites in China
Ages 18–75 · Women only
Sun Yat-sen University · Sites in China
Ages 18–70 · Women only
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 474 Uterine Cervical Neoplasms studies recruiting now, 243 (51%) set no upper age limit and 191 (40%) stop at 75 or younger; 20 take children under 18; 69 take healthy volunteers.
This study: 18 Years to 70 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
455 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 78 · Phase 2 174 · Phase 3 67 · Phase 4 6
First in 2005; this study’s year is marked. 61 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is close to the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Median enrollment 90 across the 360 interventional studies, 460 across the 95 observational. Of the 86 that completed or were terminated, 12 (14%) have results posted.
This tab as a report to print or save as PDF → With an account.
121 of 455 have an industry lead sponsor. The 10 most frequent:
Grit Biotechnology is the lead sponsor of 30 studies on the registry; 17 are open to participants now.
Grit Biotechnology has 1 study filed under Uterine Cervical Neoplasms — fewer than ten, so there is no comparison to draw.
53 of the studies in Uterine Cervical Neoplasms with a site in China that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06459687Phase 3Lee's Pharmaceutical LimitedPhase III Study of Socazolimab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer | 2027-09-01 |
| NCT04422366Phase 3Shanghai Bovax Biotechnology Co., Ltd.Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females | 2027-09-15 |
| NCT06079671Phase 3AstraZenecaStudy of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical) | 2027-11-26 |
| NCT06416696Cancer Institute and Hospital, Chinese Academy of Medical SciencesToripalimab for High-risk Locally Advanced Cervical Cancer | 2026-12 |
| NCT07860203Catherin ZhangStellate Ganglion Block and Dexmedetomidine for Postoperative Sleep in Women Undergoing Laparoscopic Gynecologic Surgery | 2026-12 |
Add all 53 to your calendar (.ics) → With an account.
Among the 455 studies in Uterine Cervical Neoplasms with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Grit Biotechnology is the lead sponsor of 30 studies on the registry; 17 are open to participants now.
Compared within Uterine Cervical Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Recurrence. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The criteria were revised on the registry on Nov 9, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After randomization, the investigator selects an appropriate surgical regimen to harvest tumor tissue for GT101 manufacture. Upon successful manufacture, participants receive lymphodepleting chemotherapy, GT101 infusion, and post-infusion intravenous bolus of interleukin-2 (IL-2).
Biological: GT101 · Biological: IL-2
After randomization, participants receive gemcitabine.
Drug: Gemcitabine injection
Progression Free Survival (PFS) (per RECIST V.1.1) by IRC assessment
Defined as time from first study treatment until disease progression per Response Evaluation Criteria in Solid Tumors \[RECIST Version 1.1\] as assessed by the Independent Review Committee (IRC) or death from any cause, whichever occurs first.
Time frame: Up to 2 years post infusion
Duration of Response (DOR)
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) (per RECIST 1.1) as assessed by IRC and Investigator respectively or death due to any cause, whichever occurs first.
Time frame: Up to 2 years post infusion
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: Up to 2 years post infusion
Overall Survival (OS)
The time from randomization until death due to any cause.
Time frame: Up to 2 years post infusion
Objective Response Rate (ORR)
The percentage of participants who achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) (per RECIST 1.1) as assessed by IRC and Investigator respectively.
Time frame: Up to 2 years post infusion
Disease Control Rate (DCR)
The percentage of participants who achieve a Best Overall Response (BOR) of CR, PR, or SD (per RECIST 1.1) as assessed by IRC and Investigator respectively.
Time frame: Up to 2 years post infusion
Progression Free Survival (PFS) (per RECIST V.1.1) by investigator assessment
The time from first study treatment until disease progression (per RECIST 1.1) as assessed by Investigator or death from any cause, whichever occurs first.
Time frame: Up to 2 years post infusion
Progression Free Survival (PFS) (per iRECIST) by IRC and investigator assessment respectively
Defined as time from first study treatment until disease progression (per iRECIST) as assessed by IRC and Investigator respectively, or death from any cause, whichever occurs first.
Time frame: Up to 2 years post infusion
Association between changes in peripheral blood TIL cells and efficacy of GT101
Observe the association between changes in peripheral blood tumor-infiltrating lymphocyte (TIL) cells before and after infusion and the efficacy of GT101 in participants.
Time frame: Up to 2 years post infusion
Change in cytokine levels
Monitor changes in cytokine levels before and after infusion
Time frame: Up to 2 years post infusion
Started Apr 2024 (actual). Primary completion is estimated for Jan 2027, 33 months after the start.
Of 50 industry-sponsored phase 2 interventional studies under Uterine Cervical Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 46. This study's planned 33 months is close to that.
Counting every sponsor, half of 204 studies reached it within 42 months; a quarter within 29 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Dimethyl-2-(tetrahydro-2-furanyl)ethylsulfonium