Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Solid Tumors

Last updated: February 13, 2025
Sponsor: Grit Biotechnology
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neuroblastoma

Neoplasms

Treatment

GT201

Clinical Study ID

NCT05729399
GRIT-CD-MED-CHN-001
  • Ages 18-70
  • All Genders

Study Summary

This study is a multi-center, single-arm phase I clinical trial. A total of 26~42 subjects (20 evaluable cases are expected) from 1 cohort will be enrolled in this study.

An "autologous tumor-infiltrating lymphocyte therapy" dosing regimen consisting of lymphodepleting chemotherapy (FC regimen: cyclophosphamide + fludarabine), infusion of autologous tumor-infiltrating lymphocyte injection, and interleukin-2 injection will be used.The study process is divided into: screening period, sampling and production period, clearing and chemotherapy period, treatment and observation period, and follow-up period

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 1.Voluntarily enrolled in the study, signed an informed consent form, and willingand able to comply with the study protocol.

2.At least one lesion (preferably superficial lymph nodes) that has not been treatedwith radiation, has not received other local therapies, has access to tumor tissue,and can isolate at least a mass ≥ 1.0 g of tissue mass (either single lesion sourceor multiple lesions combined) for the preparation of autologous tumor-infiltratinglymphocytes.

3.Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.

Exclusion

Exclusion Criteria:

  • 1.Failure of surgery and/or radiation therapy to relieve spinal cord compression isnot eligible for enrollment.

2.People with uncontrolled tumor-related pain as judged by the investigator. 3.Riskof major bleeding as assessed by investigators. 4.Have interstitial pneumonia orclinically significant active pneumonia at screening, or other respiratory diseasethat severely affects lung function.

5.Any active autoimmune disease 14 days prior to clear lymphatic chemotherapy,history of autoimmune disease, or disease requiring systemic steroid hormone orimmunosuppressive drug therapy .

6.History of allergic reaction to any component of the drugs to be used in the study (including but not limited to autologous tumor infiltrating lymphocytes,cyclophosphamide, fludarabine, interleukin-2, dimethyl sulfoxide (DMSO), human serumalbumin (HSA), dextran-40, antibiotics (beta-lactam antibiotics, gentamicin)); 7.Women who are pregnant or breastfeeding;

Study Design

Total Participants: 42
Treatment Group(s): 1
Primary Treatment: GT201
Phase: 1/2
Study Start date:
September 14, 2022
Estimated Completion Date:
May 01, 2025

Connect with a study center

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu
    China

    Active - Recruiting

  • Shanghai Tenth People's Hospital

    Shanghai, Shanghai 200072
    China

    Site Not Available

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