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Advanced Solid TumorsPhase 1/2NCT06144671

Phase I/II Clinical Study of GT201 Injection as Monotherapy or in Combination With PD-1 Inhibitor for Advanced Solid Tumors

A Phase 1/2 study testing GT201, IL-2 and PD-1 inhibitor in people with Advanced Solid Tumors, run by Grit Biotechnology at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a multicenter Phase I/II clinical trial. It aims to evaluate the safety, tolerability, efficacy and pharmacokinetics (PK) of GT201 in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
GT201, IL-2 and PD-1 inhibitor
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
2 sitesChina
Study dates
1 Nov 2025to 30 Dec 2027
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

  • 1. Voluntarily enroll in the study, sign the informed consent form (ICF), and be willing and able to comply with the study protocol.
  • 2. Aged 18 to 70 years old. For subjects older than 70 years old, eligibility shall be jointly determined by the Investigator and the Sponsor's Medical Monitor.
  • 3. Diagnosis:
  • Phase I trial: Patients with advanced solid tumors who have failed standard therapy, have no available standard therapy, or cannot tolerate standard therapy.
  • Phase II trial: Patients with the target indication who have progressed or are intolerant after receiving the specified treatment outlined in the protocol, and who meet the inclusion and exclusion criteria for the target indication.
  • 4. At least one lesion that is resectable for the preparation of autologous TIL cells.
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  • 5. At least one measurable lesion that meets the definition of RECIST v1.1 after tumor sampling.
  • 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • 7. Estimated survival time ≥ 12 weeks.
  • 8. Functions of major organs meet the requirements specified in the protocol.
  • 9. Female or male subjects of childbearing potential who have not undergone surgical sterilization must agree to use at least one medically acceptable contraceptive method (e.g., intrauterine device, oral contraceptives, condoms) during study treatment and for 1 year after the end of study treatment. For female subjects of childbearing potential without surgical sterilization, serum human chorionic gonadotropin (hCG) test must be negative within 7 days prior to cell infusion.
  • 10. Prior treatment related adverse events shall have recovered to Grade ≤ 1 per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 before tumor sampling, or be judged by the investigator together with the sponsor's medical monitor not to interfere with the study.
  • 11. For participants enrolled in this study due to disease progression, imaging documentation confirming disease progression following the prior therapy must be available before tumor sampling.

Who cannot join

  • 1. Patients with spinal cord compression not relieved by surgery and/or radiotherapy are excluded. (Patients may be enrolled if clinical evidence confirms symptom relief for ≥ 1 week prior to tumor harvesting.)
  • 2. Participants with uncontrolled tumor related pain as judged by the investigator. Participants requiring analgesic medications must have a stable analgesic regimen at study entry. Symptomatic lesions suitable for palliative radiotherapy should have completed treatment prior to study entry.
  • 3. Bleeding events within 3 months prior to screening.
  • 4. Patients with arterio-venous thrombotic events that occurred within 6 months prior to screening.
  • 5. Respiratory disorders that severely impair pulmonary function at screening.
  • 6. History of clinically significant cardiovascular disease, including but not limited to:
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  • Congestive heart failure (New York Heart Association [NYHA] Class >grade II);
  • Unstable angina pectoris;
  • Myocardial infarction within the previous 3 months;
  • Any supraventricular or ventricular arrhythmia requiring treatment or intervention.
  • 7. Participants with ≥ 3 untreated central nervous system (CNS) metastases.
  • 8. Any active autoimmune disease, history of autoimmune disease, or diseases requiring systemic corticosteroids (>10 mg prednisone daily or equivalent) or immunosuppressive agents.
  • 9. Malignant tumors other than the target indication within 5 years.
  • 10. Presence of intractable epilepsy, medically uncontrolled pleural effusion, ascites, pericardial effusion, or any contraindication to IL-2 administration.
  • 11. Active infectious diseases within 1 year prior to screening, such as HIV infection, syphilis, active hepatitis, active pulmonary tuberculosis, active Epstein-Barr virus (EBV) and/or cytomegalovirus (CMV) infection; OR history of active pulmonary tuberculosis infection more than 1 year ago without standard treatment; active hepatitis B or hepatitis C.
  • Participants positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) may enroll if HBV DNA level is below the lower limit of quantification (LLOQ) of the local study laboratory.
  • Participants positive for HCV antibody may enroll if HCV RNA level is below the LLOQ of the local study laboratory.
  • Participants with EBV DNA above the laboratory LLOQ may enroll if the Investigator assesses the viremia is tumor-related and the infection is non-active.
  • Carriers enrolled in the study shall receive antiviral therapy at the Investigator's discretion, with regular quantitative nucleic acid testing scheduled throughout the study period.
  • 12. Use of anti angiogenic agents such as bevacizumab within 4 weeks before surgical sampling.
  • 13. Previous allogeneic bone marrow transplantation or solid organ transplantation.
  • 14. Receipt of systemic anti tumor therapy within 4 weeks prior to lymphodepleting chemotherapy, except for the following:
  • Bridging therapy;
  • If prior chemotherapy with nitrosoureas or mitomycin C was administered, an interval of no less than 6 weeks between the end of such chemotherapy and the anticipated date of lymphodepleting chemotherapy is required for enrolment;
  • If prior small molecule targeted therapy was administered, an interval of no less than 5 half lives of the agent between the end of such therapy and the anticipated date of lymphodepleting chemotherapy is required for enrolment.
  • 15. Prior receipt of genetically modified or gene edited cell therapy products (excluding non genetically modified autologous immune cell therapy products administered more than 1 year before the date of cell infusion).
  • 16. History of hypersensitivity reaction to any component of investigational products to be used in the study, including but not limited to autologous TIL, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran 40, antibiotics (β-lactam antibiotics, gentamicin).
  • 17. Known psychiatric illness, alcoholism, drug addiction or substance abuse.
  • 18. Prior immune therapy related adverse events of Grade 3 or higher that have not recovered to CTCAE Grade 1 or less within 28 days; or any other disease or medical condition (any other illness, metabolic disorder, physical finding abnormality or laboratory abnormality) that would raise reasonable concerns prohibiting the use of investigational product, confound the interpretation of study results, or place the participant at high risk of treatment related complications.
  • 19. Pregnant or lactating women; or women with plans for pregnancy, conception or lactation within 1 year after the end of study treatment.
  • 20. Receipt of other investigational medicinal products within 4 weeks prior to lymphodepleting chemotherapy, or plan to receive other investigational medicinal products during the study.
  • 21. Other conditions deemed ineligible for enrollment at the investigator's discretion.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yue He, PhD contact

+86- 13501950200

william5218@126.com

China2 sites, 2 recruiting

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610000

    Lei Liu, PhD, +86 18980606231, 32498600@qq.com

    Lei Liu, PhD

    Recruiting

  • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200000

    Yue He, PhD, +86- 13501950200, william5218@126.com

    Yue He, PhD

    Recruiting

Other trials in China

About this study

Official title: Phase I/II Clinical Study of Autologous Tumor-Infiltrating Lymphocyte Injection (GT201 Injection) as Monotherapy or in Combination With PD-1 Inhibitor for Advanced Solid Tumors

This is a multicenter Phase I/II clinical trial. It aims to evaluate the safety, tolerability, efficacy and pharmacokinetics (PK) of GT201 in patients with advanced solid tumors.

Being tested
GT201, IL-2, PD-1 inhibitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GT201Biological

    Infusion

  • IL-2Biological

    Injection

  • PD-1 inhibitorBiological

    Injection

Study groups in NCT06144671
Study groupRoleWhat they receive
GT201 treatment groupExperimentalThe treatment groups consist of monotherapy and combination therapy with PD-1. The monotherapy treatment is lymphodepleting chemotherapy followed by infusion of GT201 injection and IL-2. The combination therapy is lymphodepleting chemotherapy followed by infusion of GT201 injection and IL-2, along with continuous administration of PD-1 inhibitor therapy.
Receives: Biological: GT201; Biological: IL-2; Biological: PD-1 inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events (AEs)

    Incidence and severity of AEs, SAEs and AE leading to treatment interruption and discontinuation will be graded per NCICTCAE v5.0 (Phase 1)

    Measured: Up to 2 years

  2. Changes in laboratory parameters

    Evaluate the safety and tolerability based on changes in laboratory parameters before and after treatment. (Phase 1)

    Measured: Up to 2 years

  3. Objective Response Rate (ORR)

    Proportion of participants achieving a Complete Response (CR) or Partial Response (PR) per RECIST 1.1 (Phase 2).

    Measured: Up to 2 years

Secondary outcomes (9)

  1. Objective Response Rate (ORR)

    Proportion of participants achieving a Complete Response (CR) or Partial Response (PR) per RECIST 1.1 (Phase 1).

    Measured: Up to 2 years

  2. Disease control rate (DCR)

    Proportion of participants achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST 1.1 (Phase 1 and Phase 2).

    Measured: Up to 2 years

  3. Progression free survival (PFS)

    The time from GT201 infusion to the first documentation of progressive disease (PD) per RECIST 1.1 or death from any cause, whichever occurs first (Phase 1 and Phase 2).

    Measured: Up to 2 years

  4. Duration of Response (DOR)

    The duration from the first confirmed objective response per RECIST 1.1 to the first documentation of progressive disease (PD) or death from any cause (Phase 1 and Phase 2).

    Measured: Up to 2 years

  5. Overall survival (OS)

    The time from GT201 infusion to death from any cause (Phase 1 and Phase 2).

    Measured: Up to 2 years

  6. CD3+ T cell counts

    To evaluate the persistence and expansion of TILs in participants by measuring CD3+ T cell counts in peripheral blood following infusion of GT201 Injection (Phase 1 and Phase 2).

    Measured: Up to 2 years

  7. GT201 gene copy numbers

    To evaluate the persistence and expansion of TILs in participants by measuring GT201 gene copy numbers in peripheral blood following infusion of GT201 Injection (Phase 1 and Phase 2).

    Measured: Up to 2 years

  8. Adverse events (AEs)

    Incidence and severity of AEs, SAEs and AE leading to treatment interruption and discontinuation will be graded per NCICTCAE v5.0 (Phase 2)

    Measured: Up to 2 years

  9. Anti-drug antibodies (ADA)

    Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (Nab) (Phase 1 and Phase 2).

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2023
  2. Study start1 Nov 2025
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

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
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06144671
Sponsor's protocol ID
GT-CD-CHN-201-01
Status last verified
Aug 2026
First submitted
20 Oct 2023
Last updated
19 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GT201, IL-2 and PD-1 inhibitor in people with Advanced Solid Tumors, run by Grit Biotechnology at 2 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 13 inclusion and 32 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 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 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 Yue He, PhD (+86- 13501950200, william5218@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (AEs) (time frame: Up to 2 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?

On the ClinicalTrials.gov record for NCT06144671.

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 19 Aug 2026.

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