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進行性固形腫瘍の治療のための GT201 注射剤

2026年11月6日 更新者：Grit Biotechnology

進行性固形腫瘍の治療を目的とした自己腫瘍浸潤リンパ球注射 (GT201) の単群第 I/II 相臨床研究

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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

78

段階

  • フェーズ2
  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～70年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
生物学的：GT201

Infusion

生物学的：IL-2

Injection

生物学的：PD-1 inhibitor

Injection

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Adverse events (AEs)
時間枠：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
時間枠：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)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Objective Response Rate (ORR)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：Up to 2 years

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Grit Biotechnology

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年11月1日

一次修了 (推定)

2027年12月30日

研究の完了 (推定)

2027年12月30日

試験登録日

最初に提出

2023年10月20日

QC基準を満たした最初の提出物

2023年11月17日

最初の投稿 (実際)

2023年11月22日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月9日

QC基準を満たした最後の更新が送信されました

2026年11月6日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • GT-CD-CHN-201-01

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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