研究概要
在这项1期试验中,17例转移性检查点抑制剂耐药黑色素瘤患者接受了TILT-123和TIL治疗,未进行预处理化疗或后处理IL-2。
中文摘要
TIL(肿瘤浸润淋巴细胞)(TILs)在转移性黑色素瘤(MM)治疗中有效,但毒性限制了其应用。TILT-123(igrelimogene litadenorepvec)是一种溶瘤腺病毒,复制时可产生白细胞介素-2(IL-2)和肿瘤坏死因子(TNF)。在这项1期试验中,17例转移性检查点抑制剂耐药黑色素瘤患者接受TILT-123和TILs治疗,未进行预处理化疗或后处理IL-2。该治疗安全可行。根据计算机断层扫描(CT),客观缓解率为11.7%(2/17),35%(6/17)观察到疾病控制,包括一例持续>8个月的部分缓解和一例黏膜黑色素瘤患者的持久完全缓解。根据正电子发射断层扫描(PET),7/15(47%)观察到疾病控制,4/15(27%)为轻微或部分缓解。在试验的初始TILT-123单药治疗阶段,CT和PET分别观察到6/17(35%)和10/16(63%)的疾病控制。该研究显示出良好的耐受性和初步疗效。
展开英文摘要原文
Tumor-infiltrating lymphocytes (TILs) are effective in the treatment of metastatic melanoma (MM), but toxicity limits its application. TILT-123 (igrelimogene litadenorepvec) is an oncolytic adenovirus producing interleukin-2 (IL-2) and tumor necrosis factor (TNF) upon replication. In this phase 1 trial, 17 patients with metastatic checkpoint inhibitor-resistant melanoma are treated with TILT-123 and TILs without preconditioning chemotherapy or postconditioning IL-2. The treatment is safe and feasible. According to computed tomography (CT), the objective response rate is 11.7% (2/17) and disease control is observed in 35% (6/17), including a partial response lasting >8 months and a durable complete response in a mucosal melanoma patient. According to positron emission tomography (PET), disease control is observed in 7/15 (47%) with minor or partial responses in 4/15 (27%). In the initial TILT-123 monotherapy phase of the trial, disease control is observed in 6/17 (35%) and 10/16 (63%) in CT and PET, respectively. The study demonstrates good tolerability and preliminary efficacy.
论文信息
- 作者
- Monberg TJ、Pakola SA、Albieri B、Ellebaek E、Donia M、Eefsen RL、Borch TH、Kudling TV
- 第一作者单位
- National Center for Cancer Immune Therapy (CCIT-DK), Department of Oncology, Copenhagen University Hospital, 2730 Herlev, Denmark.Denmark
- 通讯作者单位
- National Center for Cancer Immune Therapy (CCIT-DK), Department of Oncology, Copenhagen University Hospital, 2730 Herlev, Denmark. Electronic address: inge.marie.svane@regionh.dk.Denmark
- 文献类型
- I 期临床试验
- 期刊
- Cell reports. Medicine2025 Mar 18