Adult Gynecological TumorsEarly Phase 1NCT06834542
Clinical Study of GT201 in the Treatment of Advanced Gynecological Tumors
A Early Phase 1 study testing Autologous tumor infiltrating lymphocyte injection（GT201） in people with Adult Gynecological Tumors, run by Grit Biotechnology at 1 site in China.
Trial summary
This study is an early exploration clinical study with one arm. The study consists of two stages, namely the dose escalation stage and the dose extension stage: Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Adult Gynecological Tumors
- What is being tested?
- Autologous tumor infiltrating lymphocyte injection（GT201）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 30 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The 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;
- The physical fitness status score of the ECOG is 0 or 1
- At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. The separated tissues mass weighing ≥1.0g (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;
Who cannot join
- The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (>10 mg/day of prednisone or equivalent hormone);
- Arterial/venous thrombotic events within 6 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
- Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever > 38.5℃ occurring during the screening period, except for tumor fever;
- Patients who have received allogeneic bone marrow transplantation or an organ allograft;
- Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin)
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiaotong University School of Medcine, Renji Hospital Ethica Committee
Shanghai, Shanghai Municipality
About this study
Official title: Single Arm Clinical Study of Autologous Tumor Infiltrating Lymphocyte Injection (GT201) in the Treatment of Advanced Gynecological Tumors
This study is an early exploration clinical study with one arm. The study consists of two stages, namely the dose escalation stage and the dose extension stage:
- Conditions
- Adult Gynecological Tumors
- Being tested
- Autologous tumor infiltrating lymphocyte injection（GT201）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous tumor infiltrating lymphocyte injection（GT201）Biological
GT201 treatment for advanced gynecological tumors (advanced cervical cancer)
| Study group | Role | What they receive |
|---|---|---|
| GT307 injection treatment group | Experimental | Not described Receives: Biological: Autologous tumor infiltrating lymphocyte injection（GT201） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator
Measured: 3 years
Incidence and severity of adcersed events per CTCAE 5.0
To characterize the safety profile of autologous TIL injection（GT201) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adcersed events per CTCAE 5.0
Measured: 3 years
Progression-Free Survival
To evaluate efficacy parameters such Progression-Free Survival (PFS) per RECIST 1.1, as assessed by the Investigator
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 posted19 Feb 2025
- Study start1 Nov 2022
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Why it stopped: The study was terminated from a business perspective.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Gynecological TumorsStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grit Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834542
- Sponsor's protocol ID
- GRIT-CD-MED-CHN-002
- Status last verified
- Apr 2026
- First submitted
- 5 Feb 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm Clinical Study of Autologous Tumor Infiltrating Lymphocyte Injection (GT201) in the Treatment of Advanced Gynecological Tumors
- ClinicalTrials.gov ID
- NCT06834542
- Acronym / sponsor ID
- GRIT-CD-MED-CHN-002
- Conditions
- Adult Gynecological Tumors
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated from a business perspective.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Grit BiotechnologyIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 19 Feb 2025 (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 study is an early exploration clinical study with one arm. The study consists of two stages, namely the dose escalation stage and the dose extension stage:
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GT307 injection treatment group | Experimental | Biological: Autologous tumor infiltrating lymphocyte injection（GT201） |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The 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;
- The physical fitness status score of the ECOG is 0 or 1
- At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. The separated tissues mass weighing ≥1.0g (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;
Key exclusion criteria (5 listed)
- The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (>10 mg/day of prednisone or equivalent hormone);
- Arterial/venous thrombotic events within 6 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
- Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever > 38.5℃ occurring during the screening period, except for tumor fever;
- Patients who have received allogeneic bone marrow transplantation or an organ allograft;
- Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin)
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 |
|---|---|---|
| Autologous tumor infiltrating lymphocyte injection（GT201）GT201 treatment for advanced gynecological tumors (advanced cervical cancer) | Biological | GT307 injection treatment group |
Primary outcome
Objective Response Rate
Time frame: 3 years
To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator
Incidence and severity of adcersed events per CTCAE 5.0
Time frame: 3 years
To characterize the safety profile of autologous TIL injection（GT201) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adcersed events per CTCAE 5.0
Progression-Free Survival
Time frame: 3 years
To evaluate efficacy parameters such Progression-Free Survival (PFS) per RECIST 1.1, as assessed by the Investigator
Results and safety
The study was stopped early (reason given: The study was terminated from a business perspective.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Autologous tumor infiltrating lymphocyte injection（GT201） in people with Adult Gynecological Tumors, run by Grit Biotechnology at 1 site 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 3 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: stopped early, as of the sponsor's last update on 27 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 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated from a business perspective.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 3 years). The study lists 3 primary outcomes in all. 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 27 Apr 2026.