Autologous Tumor Infiltrating Lymphocyte Injection for the Treatment of Advanced Solid Tumors

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

Phase

1

Condition

Neuroblastoma

Neoplasms

Treatment

GT316

Clinical Study ID

NCT06094426
GRIT-CD-CHN-316-001
  • Ages 18-70
  • All Genders

Study Summary

This trial is a multicenter, single-arm, open design designed to evaluate the safety and tolerability of Autologous Tumor Infiltrating Lymphocyte Injection in the treatment of patients with advanced solid tumors, as well as pharmacokinetic profiling and efficacy. The trial consists of two phases: dose-escalation and dose-expansion.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 1.The Patients (or legally authorized representative) Patients (or legallyauthorized representative) must have the ability to understand the requirements ofthe study, have provided written informed consent as evidenced by signature on aninformed consent form (ICF) approved by an Institutional Review Board/IndependentEthics Committee (IRB/IEC), must have the ability to understand the requirements ofthe study;

  • 2.Must have a confirmed diagnosis of malignancy of their receptive histologies orcytologies: unresectable recurrent or metastatic solid tumor;

  • 3.At least one resectable lesion (preferably superficial metastatic lymph nodes)that has not been treated with radiation and has not received other local therapies.The separated tissues ≥1.0cm^3 (either of single lesion origin or multiple lesionscombined) for the preparation of autologous tumor-infiltrating lymphocytes.Minimally invasive treatment where possible;

Exclusion

Exclusion Criteria:

  • 1.Patients with ≥3 untreated CNS metastases at the time of screening (patients wereincluded if they had ≤3 CNS metastases with a maximum diameter of <1 cm and noperitumor edema on brain imaging (MRI or CT) and no evidence of progressive CNSdisease on brain imaging for at least 3 months after treatment)

  • 2.The patient who has any active autoimmune disease, history of autoimmune disease,need for systemic steroid hormones or a condition requiring immunosuppressive drugtherapy (>10 mg/day of prednisone or equivalent hormone);

  1. Arterial/venous thrombotic events within 3 months prior to enrollment, such as:cerebrovascular accident, deep vein thrombosis and pulmonary embolismoccurring;
  • 4.Patients with refractory or intractable epilepsy, drug-uncontrolled pleuraleffusion, abdominal effusion, pericardial effusion, active gastrointestinal bleedingor contraindications to IL-2;

  1. Participate in other clinical trials within 4 weeks prior to screening, orplanning to participate in this study and other clinical trials at the same;
  1. Patients who have received allogeneic bone marrow transplantation or an organallograft;
  • 7.Patients who have a history of hypersensitivity to any component or excipient ofstudy drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide,fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40and antibiotics (beta lactam antibiotics, gentamicin);

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: GT316
Phase: 1
Study Start date:
February 26, 2023
Estimated Completion Date:
February 26, 2026

Connect with a study center

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Active - Recruiting

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