Efficacy and Safety of TILs in Treatment of Patients With Advanced or Metastatic Refractory Gynecological Cancer

Официальное название

Efficacy and Safety of Autologous Tumor-infiltrating Lymphocytes in Treatment of Patients With Advanced or Metastatic Refractory Gynecological Cancer: a Prospective Multicenter One-arm Phase Ⅱ Trial

Обзор

Prospective, multicenter, single-arm, open label, interventional basket trial to evaluate autologous tumor-infiltrating lymphocytes (TILs) infusion followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparation for the treatment of patients with advanced or metastatic refractory gynecological cancer including cervical, ovarian, endometrial and breast carcinoma.

Подробное описание

Autologous tumor-infiltrating lymphocytes (TILs) infusion is highly personalized cancer immunotherapy with strong anti-tumor efficacy and tumor specificity. TILs were extracted from autologous fresh tumor tissues, and after ex vivo stimulation, activation and extensive expansion, are reinfused to patients. TIL-based therapies have only been offered in small phase I/II studies in a few centers and revealed a high objective response rate (ORR) in the treatment of metastatic, recurrent or advanced melanoma, non-small cell long carcinoma and cervical carcinoma. However, the efficacy of TIL-based therapies still needs more clinical trials to prove. In this proposal, a one-arm, open, multicenter, phaseⅠ/Ⅱ trial was designed to evaluate the efficacy and safety of autologous tumor-infiltrating lymphocytes in treatment of patients with advanced or metastatic refractory gynecological cancer including cervical, ovarian, endometrial and breast carcinoma.

Вмешательства

• Биопрепарат Autologous tumor-infiltrating lymphocytes
  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

• Objective Response Rate [Срок оценки: Up to 6 months]

Вторичные конечные точки (4)

• Disease Control Rate [Срок оценки: Up to 60 months]
• Progression-Free Survival [Срок оценки: Up to 60 months]
• Overall Survival [Срок оценки: Up to 60 months]
• Adverse Events [Срок оценки: Up to 60 months]

Критерии участия

Критерии включения

Participants eligible for inclusion in this study must meet all of the following criteria: Signed informed consent must be obtained prior to participation in the study.

• Aged 18-75 years old at the time of consent
• Participants are diagnosed with advanced or metastatic cervical cancer, ovarian cancer, endometrial cancer or breast cancer with radiology and pathology confirmation.
• Failure of two or more Lines of Chemotherapy, or not amenable to curative treatment.
• At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to extract TIL
• At least one measurable target lesion, that can be accurately measured in at least one dimension with longest diameter ≥20 mm, as defined by RECIST v1.1
• All the chemotherapy or radiotherapy targeting the malignant tumors must be discontinued at least 28 days prior to the tumor resection.
• No serious abnormality of complete blood count and Cardiac, Liver, and Kidney function

Критерии исключения

• Participants who have received organ transplantation or prior cell transfer therapy
• Any active autoimmune disease or history of autoimmune disease, or history of primary immunodeficiency.
• Patients who are taking systemic steroid therapy
• Patients with confirmed HIV infection, or other uncontrolled active viral infections, or serious system infections
• Patients with serious complications of heart, lung, liver, kidney, not suitable for enrollment.
• Patients with suspicious or confirmed brain metastases of any size and any number.
• Suffered from any other malignancy within 5 years (except for fully treated in situ malignant such as breast cancer, bladder cancer, cutaneous basal cell carcinoma or squamous cell carcinoma)
• Patients who are pregnant or breastfeeding
• Any other conditions judged by the researcher will significantly increase the risk of participation.

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: NCT05152797 · PRO2021-1428

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗