Solid TumorEarly Phase 1NCT05724732
Exploratory Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Gynecologic Tumors
A Early Phase 1 study testing GT201 in people with Solid Tumor, run by RenJi Hospital at 1 site in China.
Trial summary
This study is a single-center, single-arm phase I clinical trial. A total of 24~26 subjects (20 evaluable cases are expected) from 1 cohort will be enrolled in this study. An "autologous tumor-infiltrating lymphocyte therapy" dosing regimen consisting of lymphodepleting chemotherapy (FC regimen: cyclophosphamide +… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Solid Tumor
- What is being tested?
- GT201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 1 May 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol.
- 2.Patients with advanced cervical cancer, ovarian cancer, endometrial cancer and other gynecological tumors who have progressed or are intolerant to at least first-line therapy, or who are not suitable for existing first-line therapy.
- 3.At least one lesion (preferably superficial lymph nodes) that has not been treated with radiation, has not received other local therapies, has access to tumor tissue, and can isolate at least a mass ≥ 1.0 g of tissue mass (either single lesion source or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes.
- 4.Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.
Who cannot join
- 1.Failure of surgery and/or radiation therapy to relieve spinal cord compression is not eligible for enrollment.
- 2.People with uncontrolled tumor-related pain as judged by the investigator. 3.Risk of major bleeding as assessed by investigators. 4.Have interstitial pneumonia or clinically significant active pneumonia at screening, or other respiratory disease that severely affects lung function.
- 5.Any active autoimmune disease 14 days prior to clear lymphatic chemotherapy, history of autoimmune disease, or disease requiring systemic steroid hormone or immunosuppressive drug therapy .
- 6.History of allergic reaction to any component of the drugs to be used in the study (including but not limited to autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, interleukin-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40, antibiotics (beta-lactam antibiotics, gentamicin)); 7.Women who are pregnant or breastfeeding;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Wen Di, PhD, +86 13701642665, diwen163@163.com
About this study
Official title: A Single-center, Single-arm Exploratory Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for the Treatment of Advanced Gynecologic Tumors
This study is a single-center, single-arm phase I clinical trial. A total of 24~26 subjects (20 evaluable cases are expected) from 1 cohort will be enrolled in this study.
An "autologous tumor-infiltrating lymphocyte therapy" dosing regimen consisting of lymphodepleting chemotherapy (FC regimen: cyclophosphamide + fludarabine), infusion of autologous tumor-infiltrating lymphocyte injection, and interleukin-2 injection will be used.The study process is divided into: screening period, sampling and production period, clearing and chemotherapy period, treatment and observation period, and follow-up period
- Conditions
- Solid Tumor
- Being tested
- GT201
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GT201Biological
Autologous tumor infiltrating lymphocyte injection
| Study group | Role | What they receive |
|---|---|---|
| GT201 treatment group | Experimental | Autologous tumor infiltrating lymphocyte injection Receives: Biological: GT201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Profile Measured by Grade ≥3 TEAEs
To characterize the safety profile of autologous TIL injection（GT201) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence of Grade ≥ 3 treatment-emergent adverse events (TEAEs)
Measured: 3 years
Secondary outcomes (3)
Objective response rate
To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator
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
Overall survival
To evaluate efficacy parameters such Overall Survival (OS)
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 posted13 Feb 2023
- Study start1 Feb 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724732
- Sponsor's protocol ID
- GRIT-CD-MED-CHN-001
- Status last verified
- Feb 2023
- First submitted
- 1 Feb 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Single-arm Exploratory Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for the Treatment of Advanced Gynecologic Tumors
- ClinicalTrials.gov ID
- NCT05724732
- Acronym / sponsor ID
- GRIT-CD-MED-CHN-001
- Conditions
- Solid Tumor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 13 Feb 2023 (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 a single-center, single-arm phase I clinical trial. A total of 24~26 subjects (20 evaluable cases are expected) from 1 cohort will be enrolled in this study.
An "autologous tumor-infiltrating lymphocyte therapy" dosing regimen consisting of lymphodepleting chemotherapy (FC regimen: cyclophosphamide + fludarabine), infusion of autologous tumor-infiltrating lymphocyte injection, and interleukin-2 injection will be used.The study process is divided into: screening period, sampling and production period, clearing and chemotherapy period, treatment and observation period, and follow-up period
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GT201 treatment group | Experimental | Biological: GT201Autologous tumor infiltrating lymphocyte injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1.Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol.
- 2.Patients with advanced cervical cancer, ovarian cancer, endometrial cancer and other gynecological tumors who have progressed or are intolerant to at least first-line therapy, or who are not suitable for existing first-line therapy.
- 3.At least one lesion (preferably superficial lymph nodes) that has not been treated with radiation, has not received other local therapies, has access to tumor tissue, and can isolate at least a mass ≥ 1.0 g of tissue mass (either single lesion source or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes.
- 4.Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.
Key exclusion criteria (4 listed)
- 1.Failure of surgery and/or radiation therapy to relieve spinal cord compression is not eligible for enrollment.
- 2.People with uncontrolled tumor-related pain as judged by the investigator. 3.Risk of major bleeding as assessed by investigators. 4.Have interstitial pneumonia or clinically significant active pneumonia at screening, or other respiratory disease that severely affects lung function.
- 5.Any active autoimmune disease 14 days prior to clear lymphatic chemotherapy, history of autoimmune disease, or disease requiring systemic steroid hormone or immunosuppressive drug therapy .
- 6.History of allergic reaction to any component of the drugs to be used in the study (including but not limited to autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, interleukin-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40, antibiotics (beta-lactam antibiotics, gentamicin)); 7.Women who are pregnant or breastfeeding;
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 |
|---|---|---|
| GT201Autologous tumor infiltrating lymphocyte injection | Biological | GT201 treatment group |
Primary outcome
Safety Profile Measured by Grade ≥3 TEAEs
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 of Grade ≥ 3 treatment-emergent adverse events (TEAEs)
3 secondary outcomes
Objective response rate
Time frame: 3 years
Progression-free survival
Time frame: 3 years
Overall survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: No
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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.
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 GT201 in people with Solid Tumor, run by RenJi Hospital 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen Di, PhD (+86 13701642665, diwen163@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Profile Measured by Grade ≥3 TEAEs (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 13 Feb 2023.