Advanced Solid Tumors CancerPhase 1/2GT201NCT07766317
Autologous Tumor Infiltrating Lymphocyte (TIL) GT201 Infusion.
A Phase 1/2 study testing GT201 and IL-2 and PD-1 in people with Advanced Solid Tumors Cancer, run by Gritbio Medicine, Inc..
Trial summary
This is a multicenter, single-arm phase 1/2 clinical trial to evaluate the safety and tolerability of GT201 as a monotherapy or in combination with anti-PD-1 therapy in patients with advanced solid tumors, and to evaluate the efficacy of this therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumors Cancer
- What is being tested?
- GT201 and IL-2 and PD-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Jun 2032
- Phase
- Phase 1/2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Key eligibility criteria for inclusion in the study:
- 1 Age 18~70 years old;
- 2 Diagnosed with: Phase 1 part: Patients with advanced solid tumors who have failed all standard therapy, have no standard therapy, or are intolerant of standard therapy Phase 2a part: Patients with an advanced or metastatic solid tumor enrolled in one of three (3) indications selected for dose expansion based on Phase 1 safety and preliminary activity. Patients must have progressed on or after standard-of-care therapy, or for whom no suitable standard therapy is available;
- 3 At least one lesion that is resectable for the preparation of autologous TIL cells;
- 4 At least one measurable lesion that meets the definition of RECIST v1.1 after tumor sampling;
- 5 Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- 6 Expected survival ≥ 12 weeks;
- 7 Non-surgically sterilized women of reproductive age who agree to use at least one medically recognized method of contraception during the study treatment period and for 1 year after the end of the study treatment period; and must have a negative serum test at screening, prior NMA-LD and cell infusion.
Who cannot join
- Subjects will be excluded from the study for one or more of the following conditions:
- 1 Patients with spinal cord compression that has failed to resolve after surgery and/or radiotherapy (patients with clinical evidence that symptoms have resolved after surgery or radiation therapy for ≥ 1 week prior to surgical sampling are eligible for enrollment);
- 2 Bleeding events within 3 months prior to screening
- 3 Patients with arterio-venous thrombotic events that occurred within 3 months prior to screening
- 4 Have interstitial pneumonia or active pneumonia that is clinically significant at screening, or other respiratory conditions that severely affect lung function;
- 5 Patients who have a left ventricular ejection fraction (LVEF) < 45% or who are New York Heart Association (NYHA) Class grade > grade 2;
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- 6 Participants with ≥ 3 untreated central nervous system (CNS) metastases;
- 7 Have any historical or active autoimmune disease requiring systemic steroids, or immunosuppressive therapy (> 10 mg/day of prednisone or equivalent);
- 8 Malignant tumors other than the target indication within 5 years;
- 9 The presence of refractory or intractable epilepsy, large amounts of pleural effusion, ascites, pericardial effusion, etc. that cannot be controlled by drugs, or other contraindications to IL-2 use;
- 10 Patients with infectious diseases, will be excluded from the study; with some exceptions for HBV and HCV.
- 11 Previous allogeneic bone marrow transplantation or solid organ transplantation;
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I/II Open-Label Clinical Study of Autologous Tumor Infiltrating Lymphocyte Infusion (GT201) in the Treatment of Advanced Solid Tumors
This is a multicenter, single-arm phase 1/2 clinical trial to evaluate the safety and tolerability of GT201 as a monotherapy or in combination with anti-PD-1 therapy in patients with advanced solid tumors, and to evaluate the efficacy of this therapy.
- Conditions
- Advanced Solid Tumors Cancer
- Being tested
- GT201, IL-2 and PD-1
- Keywords
- Tumor Infiltrating Lymphocyte, TIL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GT201Biological
A tumor sample from individual participant is collected through a surgical resection for ex vivo manufacturing of GT201 TIL cell product.
IL-2 and PD-1Biological
Participants tandemly receives a lymphodepleting regimen, GT201 TIL product, and IL-2. Some participants may also receive a PD-1 inhibitor following GT201 infusion
| Study group | Role | What they receive |
|---|---|---|
| Participants with advanced solid tumors | Experimental | Not described Receives: Biological: GT201; Biological: IL-2 and PD-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of GT201 in the treatment of recurrent or metastatic solid tumors
Incidence and severity of AEs will be graded per NCICTCAE v5.0 (Phase 1)
Measured: Upto 2 years
To assess the safety of GT201 in the treatment of recurrent or metastatic solid tumors
Incidence and severity of CRS and ICANS AE's will be graded per the ASTCT criteria (Phase 1)
Measured: Upto 2 years
To assess the tolerance of GT201 and decide on the recommended Phase 2 dose.
The safest combination will be used to determine recommended dose for Phase 2 (RP2D) (Phase 1)
Measured: Upto 2 years
To assess the Objective Response Rate (ORR) of GT201 infusion in accordance with RECIST v1.1
To evaluate the proportion of participants who have a confirmed complete response (CR) or partial response (PR) (Phase 2)
Measured: Upto 2 years
Secondary outcomes (5)
To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: Objective response rate (ORR)
Proportion of participants achieving a Complete Response (CR) or Partial Response (PR) per RECIST v1.1 (Phase 1 and Phase 2)
Measured: Upto 2 years
To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: duration of response (DOR)
The duration from the first confirmed objective response per RECIST v1.1 to the first documentation of progressive disease (PD) or death from any cause (Phase 1 and Phase 2)
Measured: Upto 2 years
To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: disease control rate (DCR)
Proportion of participants achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST v1.1 (Phase 1 and Phase 2).
Measured: Upto 2 years
To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: progression free survival (PFS)
The time from GT201 infusion to the first documentation of progressive disease (PD) per RECIST v1.1 or death from any cause, whichever occurs first (Phase 1 and Phase 2)
Measured: Upto 2 years
To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: overall survival (OS)
The time from GT201 infusion to death from any cause (Phase 1 and Phase 2)
Measured: Upto 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumors CancerStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gritbio Medicine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766317
- Sponsor's protocol ID
- GT-CD-CHN-201-01
- Acronym
- GT201
- Status last verified
- Aug 2026
- First submitted
- 27 Jul 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Open-Label Clinical Study of Autologous Tumor Infiltrating Lymphocyte Infusion (GT201) in the Treatment of Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07766317
- Acronym / sponsor ID
- GT201 / GT-CD-CHN-201-01
- Conditions
- Advanced Solid Tumors Cancer
- Keywords
- Tumor Infiltrating Lymphocyte, TIL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Gritbio Medicine, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 14 Aug 2026 (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 1/2 clinical trial to evaluate the safety and tolerability of GT201 as a monotherapy or in combination with anti-PD-1 therapy in patients with advanced solid tumors, and to evaluate the efficacy of this therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with advanced solid tumors | Experimental | Biological: GT201, Biological: IL-2 and PD-1 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1 Age 18~70 years old;
- 2 Diagnosed with: Phase 1 part: Patients with advanced solid tumors who have failed all standard therapy, have no standard therapy, or are intolerant of standard therapy Phase 2a part: Patients with an advanced or metastatic solid tumor enrolled in one of three (3) indications selected for dose expansion based on Phase 1 safety and preliminary activity. Patients must have progressed on or after standard-of-care therapy, or for whom no suitable standard therapy is available;
- 3 At least one lesion that is resectable for the preparation of autologous TIL cells;
- 4 At least one measurable lesion that meets the definition of RECIST v1.1 after tumor sampling;
- 5 Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
Key exclusion criteria (12 listed)
- 1 Patients with spinal cord compression that has failed to resolve after surgery and/or radiotherapy (patients with clinical evidence that symptoms have resolved after surgery or radiation therapy for ≥ 1 week prior to surgical sampling are eligible for enrollment);
- 2 Bleeding events within 3 months prior to screening
- 3 Patients with arterio-venous thrombotic events that occurred within 3 months prior to screening
- 4 Have interstitial pneumonia or active pneumonia that is clinically significant at screening, or other respiratory conditions that severely affect lung function;
- 5 Patients who have a left ventricular ejection fraction (LVEF) < 45% or who are New York Heart Association (NYHA) Class grade > grade 2;
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 |
|---|---|---|
| GT201A tumor sample from individual participant is collected through a surgical resection for ex vivo manufacturing of GT201 TIL cell product. | Biological | Participants with advanced solid tumors |
| IL-2 and PD-1Participants tandemly receives a lymphodepleting regimen, GT201 TIL product, and IL-2. Some participants may also receive a PD-1 inhibitor following GT201 infusion | Biological | Participants with advanced solid tumors |
Primary outcome
To assess the safety of GT201 in the treatment of recurrent or metastatic solid tumors
Time frame: Upto 2 years
Incidence and severity of AEs will be graded per NCICTCAE v5.0 (Phase 1)
To assess the safety of GT201 in the treatment of recurrent or metastatic solid tumors
Time frame: Upto 2 years
Incidence and severity of CRS and ICANS AE's will be graded per the ASTCT criteria (Phase 1)
To assess the tolerance of GT201 and decide on the recommended Phase 2 dose.
Time frame: Upto 2 years
The safest combination will be used to determine recommended dose for Phase 2 (RP2D) (Phase 1)
To assess the Objective Response Rate (ORR) of GT201 infusion in accordance with RECIST v1.1
Time frame: Upto 2 years
To evaluate the proportion of participants who have a confirmed complete response (CR) or partial response (PR) (Phase 2)
5 secondary outcomes
To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: Objective response rate (ORR)
Time frame: Upto 2 years
To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: duration of response (DOR)
Time frame: Upto 2 years
To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: disease control rate (DCR)
Time frame: Upto 2 years
To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: progression free survival (PFS)
Time frame: Upto 2 years
To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: overall survival (OS)
Time frame: Upto 2 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 14 Aug 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GT201 and IL-2 and PD-1 in people with Advanced Solid Tumors Cancer, run by Gritbio Medicine, Inc..
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 12 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: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
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 Gritbio Study Team (440-414-3338, GT201.inquiries@grit-bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety of GT201 in the treatment of recurrent or metastatic solid tumors (time frame: Upto 2 years). The study lists 4 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 Aug 2026.