Solid Tumors, AdultPhase 1NCT05430373
GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors
A Phase 1 study testing GT101 in people with Solid Tumors, Adult, run by Grit Biotechnology at 5 sites in China.
Trial summary
This is a multicenter, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, lymphodepleting chemotherapy period, treatment and observation period, and follow-up period. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solid Tumors, Adult
- What is being tested?
- GT101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 5 sitesChina
- Study dates
- 23 May 2022to 30 Dec 2026
- Phase
- Phase 1
- 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
- All sexes
- 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.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor;
- 3.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
- 1. Patients who have symptomatic and/or untreated CNS metastases (Except stable brain metastases, no medication required within 3 months, no hormone dependence);
- 2.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);
- 3. Arterial/venous thrombotic events within 6 months prior to surgical operation, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
- 4.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;
- 5. Patients who have refractory or intractable epilepsy, poorly controlled hydrothorax, hydrops abdominis, active gastrointestinal bleeding or IL-2 contraindications;
- 6. Participate in other clinical trials within 28 days prior to the first dose of this study, or planning to participate in this study and other clinical trials at the same time;
- 7. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
- 8.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
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Yongsheng Wang, PhD contact
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
The fifth medical center of the General Hospital of the Chinese people's Liberation Army
Beijing, Beijing Municipality, 100039
Haifeng Qin, PhD, +86 13601365243, hifo@263.net
- Recruiting
West China School of Medicine/West China Hospital of Sichuan University
Chengdu, Sichuan, 610064
Yongsheng Wang, PhD, wangy756@163.com
- Recruiting
Chongqing University Cancer Center
Chongqing, Chongqing Municipality, 400030
Donglin Zou, PhD, 13570049@qq.com
Yongsheng Li, PhD, yongshengli2005@163.com
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201321
Jian Zhang, PhD, syner2000@163.com
Dongmei Ji, PhD
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Xiubao Ren, PhD, xiubao_ren@126.com
About this study
Official title: A Single-arm Phase I Clinical Study of GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors
This is a multicenter, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, lymphodepleting chemotherapy period, treatment and observation period, and follow-up period.
The study is designed to enroll 20-31 subjects, with 14-20 subjects expected to be evaluable, in an "autologous tumor-infiltrating lymphocyte therapy" regimen that includes：
- Clear lymphatic pretreatment (FC regimen: cyclophosphamide + fludarabine).
- GT101 infusion.
- post-infusion treatment (interleukin-2 intravenous push).
- Conditions
- Solid Tumors, Adult
- Being tested
- GT101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GT101Biological
Autologous tumor infiltrating lymphocyte injection
| Study group | Role | What they receive |
|---|---|---|
| GT101 treatment group | Other | Autologous tumor infiltrating lymphocyte injection Receives: Biological: GT101 |
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（GT101) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence of Grade ≥ 3 treatment-emergent adverse events (TEAEs)
Measured: 3 years
Objective response rate
To evaluate efficacy parameters such Objective Response Rate (ORR) 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
Progression-free survival
To evaluate efficacy parameters such Progression-Free Survival (PFS) per RECIST 1.1, as assessed by the Investigator
Measured: 3 years
Disease Control Rate
To evaluate efficacy parameters such disease control rate (DCR) per RECIST 1.1, as assessed by investigater
Measured: 3 years
Duration of Response
To evaluate efficacy parameters such duration of response (DoR) per RECIST 1.1, as assessed by investigater
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 posted24 Jun 2022
- Study start23 May 2022
- Primary completion25 Sep 2025
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumors, 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 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
- NCT05430373
- Sponsor's protocol ID
- GT101-101
- Status last verified
- Sep 2026
- First submitted
- 13 Jun 2022
- Last updated
- 14 Sep 2026
- 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 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Phase I Clinical Study of GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors
- ClinicalTrials.gov ID
- NCT05430373
- Acronym / sponsor ID
- GT101-101
- Conditions
- Solid Tumors, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Grit BiotechnologyIndustry (pharma, biotech, devices)
- Study start
- 23 May 2022 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 24 Jun 2022 (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 multicenter, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, lymphodepleting chemotherapy period, treatment and observation period, and follow-up period.
The study is designed to enroll 20-31 subjects, with 14-20 subjects expected to be evaluable, in an "autologous tumor-infiltrating lymphocyte therapy" regimen that includes：
- Clear lymphatic pretreatment (FC regimen: cyclophosphamide + fludarabine).
- GT101 infusion.
- post-infusion treatment (interleukin-2 intravenous push).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GT101 treatment group | Other | Biological: GT101Autologous tumor infiltrating lymphocyte injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 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.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor;
- 3.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 (8 listed)
- 1. Patients who have symptomatic and/or untreated CNS metastases (Except stable brain metastases, no medication required within 3 months, no hormone dependence);
- 2.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);
- 3. Arterial/venous thrombotic events within 6 months prior to surgical operation, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
- 4.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;
- 5. Patients who have refractory or intractable epilepsy, poorly controlled hydrothorax, hydrops abdominis, active gastrointestinal bleeding or IL-2 contraindications;
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 |
|---|---|---|
| GT101Autologous tumor infiltrating lymphocyte injection | Biological | GT101 treatment group |
Primary outcome
Safety Profile Measured by Grade ≥3 TEAEs
Time frame: 3 years
To characterize the safety profile of autologous TIL injection（GT101) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence of Grade ≥ 3 treatment-emergent adverse events (TEAEs)
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
Overall survival
Time frame: 3 years
To evaluate efficacy parameters such Overall Survival (OS)
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
Disease Control Rate
Time frame: 3 years
To evaluate efficacy parameters such disease control rate (DCR) per RECIST 1.1, as assessed by investigater
Duration of Response
Time frame: 3 years
To evaluate efficacy parameters such duration of response (DoR) per RECIST 1.1, as assessed by investigater
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 14 Sep 2026.
- 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.
Yongsheng Wang, PhD contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GT101 in people with Solid Tumors, Adult, run by Grit Biotechnology at 5 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 3 inclusion and 8 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 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Haifeng Qin, PhD (+86 13601365243, hifo@263.net), 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). The study lists 6 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 14 Sep 2026.