JPRN-UMIN000023276已完成1 期
Phase I trial of the Toll-like receptor 9 agonist CpG-ODN(K3) as immunotherapy for patients with recurrent/metastatic lung cancer - Phase I trial of the Toll-like receptor 9 agonist CpG-ODN(K3)
Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine0 个研究点目标入组 9 人开始时间: 2016年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
研究概览
简要总结
o DLTs at any dose level. No serious treatment-related adverse events. Serum IFN-a2 levels increased in six patients after the third administration of CpG ODN (K3). Serum IFN-g and CXCL10 levels increased in eight patients after the third administration. The percentage of T-bet-expressing CD8+ T cells increased. Both T-bet-expressing effector memory (p = 0.0195) and terminally differentiated effector memory (p = 0.0039) CD8+ T cells significantly increased. The median PFS was 398 days.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 79years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Synchronous or metachronous malignancies 2) Symptomatic brain metastasis 3) Massive pleural effusion required for tube drainage 4) Infectious disease requiring systemic treatment 5) Positive test for hepatitis B virus antigen or hepatitis C virus or human immunodeficiency virus 6) History of unstable angina or myocardial infarction 7) Interstitial pneumonia on chest CT 8) History of antiphospholipid antibody syndrome 9) Subjects with active, known or suspected autoimmune disease 10) Current use of aspirin, or anticlotting drug or thrombolytic agent 11) Receiving continuous systemic corticosteroid treatment 12) Pregnant status or lactation 13) Severe psychological disorder 14) Other ineligible status judged by medical oncologist
研究者
相似试验
进行中（未招募）
1 期
TIL and Anti-PD1 in Metastatic MelanomaToxicity, DrugAdverse Drug EventEffects of ImmunotherapyNCT03638375Leiden University34
进行中（未招募）
1 期
Safety and Immunogenicity of an Inactivated West Nile Virus Vaccine in Healthy AdultsWest Nile Viral InfectionNCT06745921National Institute of Allergy and Infectious Diseases (NIAID)30
进行中（未招募）
1 期
Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney CancerMetastatic Kidney CarcinomaStage III Renal Cell Cancer AJCC v7Stage IV Renal Cell Cancer AJCC v7Clear Cell Renal Cell CarcinomaNCT01038778National Cancer Institute (NCI)47
终止
1 期
A Study of De-immunized DI-Leu16-IL2 Administered Subcutaneously in Participants With B-cell NHLB-cell Non-Hodgkin LymphomaNCT01874288Alopexx Oncology, LLC24
Unknown
1 期
Pilot Study of FFP104 Dose Escalation in PBC SubjectsPrimary Biliary CirrhosisNCT02193360Fast Forward Pharmaceuticals24