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GT201-injectie voor de behandeling van geavanceerde solide tumoren

6 november 2026 bijgewerkt door: Grit Biotechnology

Een eenarmige fase I/II klinische studie van autologe tumor-infiltrerende lymfocyteninjectie (GT201) voor de behandeling van gevorderde solide tumoren

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

78

Fase

  • Fase 2
  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Werving
        • Sun Yat-sen University Cancer Center
        • Hoofdonderzoeker:
          • Zhiming Li, PhD
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Werving
        • Guangxi Medical University Cancer Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Song Qu, PhD
    • Hunan
      • Changsha, Hunan, China, 410013
        • Werving
        • Hunan Cancer Hospital, Xiangya School of Medicine, Central South University
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Yaqian Han, PhD
        • Hoofdonderzoeker:
          • Yongchang Zhang, PHD
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200080
        • Werving
        • Shanghai General Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Pin Dong, PhD
      • Shanghai, Shanghai Municipality, China, 200000
        • Werving
        • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
        • Hoofdonderzoeker:
          • Yue He, PhD
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Werving
        • West China Hospital, Sichuan University
        • Hoofdonderzoeker:
          • Lei Liu, PhD
        • Contact:
        • Hoofdonderzoeker:
          • Li Zheng, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • 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.

  • 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.

Exclusion Criteria:

  • 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:

    1. Congestive heart failure (New York Heart Association [NYHA] Class >grade II);
    2. Unstable angina pectoris;
    3. Myocardial infarction within the previous 3 months;
    4. 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: GT201 treatment group

The 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.
Biologisch: GT201

Infusion

Biologisch: IL-2

Injection

Biologisch: PD-1 inhibitor

Injection

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adverse events (AEs)
Tijdsspanne: Up to 2 years

Incidence and severity of AEs, SAEs and AE leading to treatment interruption and discontinuation will be graded per NCICTCAE v5.0 (Phase 1)
Up to 2 years
Changes in laboratory parameters
Tijdsspanne: Up to 2 years

Evaluate the safety and tolerability based on changes in laboratory parameters before and after treatment. (Phase 1)
Up to 2 years
Objective Response Rate (ORR)
Tijdsspanne: Up to 2 years

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Objective Response Rate (ORR)
Tijdsspanne: Up to 2 years

Proportion of participants achieving a Complete Response (CR) or Partial Response (PR) per RECIST 1.1 (Phase 1).
Up to 2 years
Disease control rate (DCR)
Tijdsspanne: Up to 2 years

Proportion of participants achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST 1.1 (Phase 1 and Phase 2).
Up to 2 years
Progression free survival (PFS)
Tijdsspanne: Up to 2 years

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).
Up to 2 years
Duration of Response (DOR)
Tijdsspanne: Up to 2 years

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).
Up to 2 years
Overall survival (OS)
Tijdsspanne: Up to 2 years

The time from GT201 infusion to death from any cause (Phase 1 and Phase 2).
Up to 2 years
CD3+ T cell counts
Tijdsspanne: Up to 2 years

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).
Up to 2 years
GT201 gene copy numbers
Tijdsspanne: Up to 2 years

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).
Up to 2 years
Adverse events (AEs)
Tijdsspanne: Up to 2 years

Incidence and severity of AEs, SAEs and AE leading to treatment interruption and discontinuation will be graded per NCICTCAE v5.0 (Phase 2)
Up to 2 years
Anti-drug antibodies (ADA)
Tijdsspanne: Up to 2 years

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Grit Biotechnology

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 november 2025

Primaire voltooiing (Geschat)

30 december 2027

Studie voltooiing (Geschat)

30 december 2027

Studieregistratiedata

Eerst ingediend

20 oktober 2023

Eerst ingediend dat voldeed aan de QC-criteria

17 november 2023

Eerst geplaatst (Werkelijk)

22 november 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 november 2026

Laatste update ingediend die voldeed aan QC-criteria

6 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • GT-CD-CHN-201-01

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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