A Clinical Study on TILs for the Treatment of Advanced Solid Tumors

Официальное название

An Exploratory Clinical Study Evaluating the Safety, Tolerance, Immune Response, and Initial Efficacy of Autologous Tumor Infiltrating Lymphocytes (TILs) LM103 Injection in Patients With Advanced Solid Tumors

Обзор

This study is an open exploratory clinical study to evaluate the safety, tolerance, immune response, and initial efficacy of autologous tumor infiltrating lymphocyte LM103 injection in advanced solid tumor patients . The research treatment includes fludarabine and cyclophosphamide, autologous tumor infiltrating lymphocytes (TILs) infusion, and Interleukin-2 therapy.

Вмешательства

• Биопрепарат LM103
  Fresh tumor samples will be resected from enrolled patients. Autologous TILs will be extracted and reinfused to corresponding patients after ex vivo stimulation, activation and extensive expansion.

Первичные конечные точки

• Adverse events (AE), Serious adverse event (SAE) and immune related adverse events (irAE) [Срок оценки: through study completion, an average of 1 year estimate]

Вторичные конечные точки (8)

• Objective response rate (ORR) [Срок оценки: through study completion, an average of 1 year estimate]
• Duration of response (DOR) [Срок оценки: through study completion, an average of 1 year estimate]
• Disease control rate (DCR) [Срок оценки: through study completion, an average of 1 year estimate]
• Time to response (TTR) [Срок оценки: through study completion, an average of 1 year estimate]
• Time to disease progression (TTP) [Срок оценки: through study completion, an average of 1 year estimate]
• Progression free survival (PFS) [Срок оценки: through study completion, an average of 1 year estimate]
• Overall survival (OS) [Срок оценки: through study completion, an average of 1 year estimate]
• Peripheral blood TILs cell survival [Срок оценки: through study completion, an average of 1 year estimate]

Критерии участия

Критерии включения

• The expected survival time is not less than 3 months.
• Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0-1.
• Patients with advanced solid tumors confirmed by histology or cytology: advanced Melanoma, cervical cancer/ovarian cancer, head and neck squamous cell cancer, non-small cell lung cancer, esophageal cancer and other solid tumors that have failed standard treatment regimens, cannot tolerate standard treatment, refuse or do not have standard treatment regimens available.
• The patient has lesions that can be used for surgical resection (>1.5 cm3) or biopsy puncture (no less than 6 lesions) for TILs collection.
• At least one measurable lesion as the target lesion after collecting tumor tissue from the patient (RECIST v1.1 criteria).
• Laboratory tests results during the screening period indicate that the subjects have sufficient organ function.

Критерии исключения

• Have a medical history of other malignant tumors other than the disease under study in the past 5 years, except for malignant tumors that can be expected to recover after treatment (including but not limited to thyroid cancer, cervical Carcinoma in situ, basal or squamous cell skin cancer or Ductal carcinoma in situ of the breast treated by radical surgery).
• LM103 received systematic Sex therapy of antineoplastic drugs (including chemotherapy, small molecule targeted drug therapy, Hormone replacement therapy, etc.), or local antineoplastic therapy (such as radiotherapy, palliative radiotherapy for bone metastases>2 weeks before the start of the study and intracranial stereotactic radiotherapy or resection of a single brain metastasis>3 weeks before the start of the study were acceptable) within 4 weeks before LM103 infusion; Or received clinical investigational drugs or equipment treatment.
• Adverse reactions caused by previous treatment have not recovered to CTCAE (version 5.0) level 1 or below (excluding hair loss and neurotoxicity, which have been determined by the researchers to be irreparable and level 2 hypothyroidism for a long time).
• Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05971576 · LM103-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗