A Clinical Study of LM103 Injection in the Treatment of Advanced Solid Tumors

Официальное название

A Single-Arm, Open-Label, Exploratory Study to Evaluate Safety and Efficacy of LM103 Injection in the Treatment of Advanced Solid Tumors

Обзор

This is a single-arm, open-label, exploratory study to evaluate safety and efficacy of LM103 Injection in patients with advanced solid tumors. The purpose of this study is to evaluate the safety and tolerability, antitumor activity and immunoreactivity.

Подробное описание

This is an investigator initiated , single-arm, open-label ,exploratory study of LM103 Injection in patients with advanced solid tumors. Expanded TILs will be transferred to the patient after chemotherapy with cyclophosphamide and fludarabine. LM103 will be administered as a single dose on day 1. TIL transfer will be combined with IL-2 treatment. This study is planned to enroll 9-15 patients with advanced solid tumors.

Вмешательства

• Препарат Autologous tumor infiltrating lymphocytes (TILs)
  A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients will be infused with LM103 Injection followed by IL-2.

Первичные конечные точки

• Incidence and severity of adverse events (AEs) [Срок оценки: Up to 1 years]

Вторичные конечные точки (4)

• Number of Participants With Objective Response [Срок оценки: Up to 2 years]
• Disease Control Rate (DCR） [Срок оценки: Up to 2 years]
• Progression-Free Survival (PFS) [Срок оценки: Up to 2 years]
• The changes of the immunoreactivity during treatment [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• AJCC (V8) stage III or IV melanoma, non-small cell lung cancer, cervical cancer and other solid tumors (confirmed by histology) for which existing treatment is ineffective or without standard treatment;
• The patient has residual lesions that can be used for surgical resection (>1.5cm3) or biopsy (>1.5cm3) and measurable after resection for TIL collection and efficacy evaluation;
• Laboratory inspection index requirements:

• Blood routine: lymphocyte ratio > 20%; neutrophil count > 1.0 × 10\^9/L; white blood cells > 3.0 × 10\^9/L; platelets > 100 × 10\^9/L; hemoglobin > 80 g/ L;
• Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ upper limit of normal x 2.5, if there is liver metastasis ≤ upper limit of normal x 5; alkaline phosphatase (ALP) ≤ upper limit of normal x 2.5; total gallbladder Red pigment (TBIL)≤normal upper limit×1.5;
• Renal function: urea ≤ upper limit of normal × 1.5; creatinine (Cr) ≤ upper limit of normal × 1.5;
• Left ventricular ejection fraction (LVEF) ≥ 50%;
• ECOG physical condition is 0 or 1;
• The expected survival time is more than 3 months;

Критерии исключения

• Suffering from active or previous autoimmune diseases ;
• Severe liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and hematopoietic dysfunction;
• Combined with severe infection or persistent infection and cannot be effectively controlled;
• Central nervous system metastasis and/or cancerous meningitis;
• With uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;
• Requires systemic steroid therapy;
• Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HbcAb); positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tianjin Beichen Hospital — Тяньцзинь

Публикации

• Li F, Wang Y, Yan J, Wu H, Du X, Feng W, Zhang X, Xue Y, Wang H, Liu W. Autologous Tumor-Infiltrating Lymphocyte Mono-Therapy Can Rapidly Shrank Tumor in Asian Patient with Stage III/IV Cervical Cancer: Two Cases Report. Int J Womens Health. 2024 Jan 9;16:31-39. doi: 10.2147/IJWH.S446768. eCollection 2024. PMID 38222312

Идентификаторы

NCT: NCT05366478 · TIL-2021001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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