An Exploratory Clinical Study to Evaluate the Safety, Tolerability, Immune Response and Preliminary Efficacy of LM103 Injection in Combination With PD-1 in Patients With Advanced Solid Tumours

Обзор

This is an exploratory clinical study evaluating the safety, tolerability, immune response and preliminary efficacy of LM103 Injection in combination with PD-1 in patients with advanced solid tumours. The research treatment includes LM103 injection, IL-2 therapy, PD-1 therapy,fludarabine and cyclophosphamide.

Вмешательства

• Биопрепарат LM103
  Patients were treated with PD-1, cyclophosphamide and fludarabine, LM103 and IL-2 treatment.

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 (7)

• 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]

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 LM103 manufacturing.
• 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 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

Китай · 1 центр

• Tianjin Beichen Hospital — China

Публикации

• Li F, Xu Y, Wang Y, Mu N, Liu M, Feng W, Xue Y, Wu S, Wang X, Lizee G, Ma C. Multiple autologous tumor-infiltrating lymphocyte (LM103 infusion) therapy combined with immune checkpoint inhibitor induces repeated tumor regression in a patient with aggressive mucosal melanoma: a case report and literature review. Front Oncol. 2026 Apr 23;16:1789442. doi: 10.3389/fonc.2026.1789442. eCollection 2026. PMID 42109657

Идентификаторы

NCT: NCT06697665 · LM-CM-TIL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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