此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

一种新型疫苗 (EO2463) 作为单一疗法和联合疗法，用于治疗惰性非霍奇金淋巴瘤患者 (SIDNEY)

2026年11月2日 更新者：Enterome

EO2463 的全球多中心 1/2 期试验，一种新型微生物衍生肽治疗性疫苗，作为单一疗法，并与来那度胺和利妥昔单抗联合治疗惰性非霍奇金淋巴瘤患者

The purpose of this study is to define the recommended Phase 2 Dose, safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 during monotherapy and in combination with lenalidomide and/or rituximab in patients with indolent NHL

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

EO2463 Is an innovative cancer peptide therapeutic vaccine based on the homologies between tumor associated antigens and microbiome-derived peptides that will be administered alone and in combination with lenalidomide, rituximab, and lenalidomide/rituximab to generate safety and preliminary efficacy data in patients with indolent NHL

研究类型

介入性

注册 (估计的)

80

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 意大利
      • Naples、意大利
        • IRCCS Policlinico San Matteo Foundation - University of Pavia
      • Pavia、意大利
        • IRCCS Policlinico San Matteo Foundation - University of Pavia
  • 法国
      • Amiens、法国
        • CHU d'Amiens-Picardie - Hopital SUD
  • 美国
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • Dana Farber Cancer Institute
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • Mayo Clinic
    • New York
      • Rochester、New York、美国、14642
        • University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center)
    • Washington
      • Seattle、Washington、美国、98109
        • University of Washington-Seattle Cancer Care Alliance
  • 西班牙
      • Barcelona、西班牙
        • University Hospital Vall d'Hebron, Institute of Oncology
      • Madrid、西班牙
        • Clinica Universidad de Navarra
      • Pamplona、西班牙
        • Clinica Universidad de Navarra
      • Salamanca、西班牙
        • Hospital Clinico Universitario de Salamanca

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. For inclusion in Cohorts 1 and 4 patients should have relapsed/refractory, biopsy-proven grade 1, 2 or 3A, FL or MZL, ECOG performance status 0 to 2, and have received at least one prior line of treatment. For inclusion in Cohort 4b the above applies except that patients with FL, and not patients with MZL, will be eligible for enrollment.
  2. For inclusion in Cohort 2 patients should have newly diagnosed, previously untreated (radiotherapy as only prior treatment is allowed), biopsy-proven grade 1, 2 or 3A, FL or MZL. ECOG performance status 0 or 1, low tumor burden by Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria, and not be in need of standard of care therapy according to the assessment of the treating physician.
  3. For inclusion in Cohort 3 patients should have newly diagnosed, previously untreated (radiotherapy as only prior treatment is allowed), biopsy-proven grade 1, 2 or 3A, FL or MZL. ECOG performance status 0 or 1, low tumor burden by GELF criteria and be in need of therapy according to the assessment of the treating physician.
  4. Patients with an age ≥ 18 years old.
  5. Patients who are human leukocyte antigen (HLA)-A2 positive.
  6. Patients should have radiologically measurable disease with a lymph node or tumor mass greater than or equal to 1.5 cm in at least one dimension.
  7. Males or non-pregnant, non-lactating, females.
  8. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.
  9. Patients having received the information sheet and who have provided written informed consent prior to any study-related procedures.

Exclusion Criteria:

  1. Patients treated with dexamethasone > 2 mg/day or equivalent (i.e. 13 mg/day of prednisone, or 53 mg/day of hydrocortisone) within 14 days before the first EO2463 administration, unless required to treat an adverse event.
  2. Patients with grade 3B FL or transformation to an aggressive lymphoma subtype.
  3. Patients with only one prior treatment and a high-risk profile as defined by first progression of disease within 24 months of diagnosis (the exclusion is not applicable for patients with more than one prior line treatment).
  4. Patients with prior exposure to EO2463.
  5. Patients treated with immunotherapy (meaning immunostimulatory or immunosuppressive therapy; beside excluded, or allowed, compounds per other inclusion/exclusion criteria specifications), radionuclide therapy, radiotherapy, cytoreductive therapy, or received treatment with any other investigational agent within 28 days before the first EO2463 administration.
  6. Patients to be included in Cohorts 1 and 4, and who have received rituximab or other B cell ablation therapy within 8 weeks of start of study treatment.
  7. Patients to be included in Cohorts 4, who received prior CAR T-cell therapy and progressed within 6 months after this therapy.
  8. Patients with abnormal laboratory values.
  9. Patients with persistent Grade 3 or 4 toxicities.
  10. Uncontrolled central nervous system (CNS) metastasis.
  11. Other malignancy or prior malignancy with a disease-free interval of less than 3 years.
  12. Patients with clinically significant disease.
  13. Patients with suspected autoimmune or active autoimmune disorder or known history of an autoimmune neurologic condition (e.g. Guillain-Barré syndrome).
  14. Patients with history of solid organ transplantation or allogeneic hematopoietic stem cell transplantation.
  15. Pregnant and breastfeeding patients.
  16. Patients with history or presence of human immunodeficiency virus and/or potentially active hepatitis B virus/hepatitis C virus infection.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：顺序分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Cohort 1

Safety Lead-In, Dose-Finding, Cohort, with a 3-by-3 design of EO2463 monotherapy for 6 weeks followed by addition of lenalidomide. Then, if applicable rituximab (depending on response with EO2463 + lenalidomide) will be added. Four to 18 previously treated patients with Follicular Lymphoma (FL) or Marginal Zone Lymphoma (MZL) were anticipated to be included based on safety findings.
生物：EO2463

Multiple dose of EO2463

药品：lenalidomide

D1-21 of 4-weekly cycles

其他名称：
  • 来那度胺
生物：rituximab

Multiple doses of rituximab

其他名称：
  • 美罗华
实验性的：Cohort 2

Anticipated approximatively 25 previously untreated patients with FL or MZL with an evaluation of EO2463 monotherapy (at the established dose in Cohort 1).
生物：EO2463

Multiple dose of EO2463
实验性的：Cohort 3

Anticipated approximatively 6 previously untreated patients with FL or MZL with an evaluation of EO2463 (at the established dose in cohort 1) as monotherapy for 6 weeks followed by addition of rituximab if applicable (depending on response with EO2463 monotherapy).
生物：EO2463

Multiple dose of EO2463

生物：rituximab

Multiple doses of rituximab

其他名称：
  • 美罗华
实验性的：Cohort 4

Anticipated approximatively 40 patients previously treated patients with FL (or MZL). Evaluation of EO2463 (at the established dose in Cohort 1) in combination with lenalidomide from day 1 and then with addition of rituximab.
生物：EO2463

Multiple dose of EO2463

药品：lenalidomide

D1-21 of 4-weekly cycles

其他名称：
  • 来那度胺
生物：rituximab

Multiple doses of rituximab

其他名称：
  • 美罗华

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Phase 1: Recommended Phase 2 Dose | Adverse Events Assessment |
大体时间：Up to 24 months

Incidences of adverse events, Treatment-Emergent Adverse events, Serious Adverse Events, Deaths, and Laboratory Abnormalities Using the National Cancer Institute-Common Terminology Criteria for Adverse events (NCI-CTCAE) V5.0.
Up to 24 months
Phase 2: Overall Response Rate
大体时间：Up to 24 months

Overall Response Rate According to the Lugano Classification 2014 during EO2463 Monotherapy
Up to 24 months
Phase 2: Complete Response Rate
大体时间：Up to 24 months

Complete remission (CR)-rate according to the Lugano Classification 2014 during therapy with the combination of EO2463/lenalidomide/rituximab.
Up to 24 months

次要结果测量

结果测量
措施说明
大体时间
Assessment of the Immunogenicity in Relation to OMP72, OMP64, OMP65, OMP66, and UCP2 that Compose EO2463
大体时间：Up to 24 months

Immunogenicity will be assessed by interferon-Gamma (IFN-Γ) enzyme-Linked immunospot , and/or by intracellular cytokines staining, and/or multimers staining assays.
Up to 24 months
Evaluation of Overall Survival
大体时间：Up to 7 years after last patient enrolled

The time interval from the date of first study treatment administration to the date of death due to any cause
Up to 7 years after last patient enrolled

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Enterome

调查人员

  • 研究主任：Jan Fagerberg, MD、Enterome

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年7月5日

初级完成 (估计的)

2029年5月30日

研究完成 (估计的)

2034年5月30日

研究注册日期

首次提交

2020年12月8日

首先提交符合 QC 标准的

2020年12月14日

首次发布 (实际的)

2020年12月16日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • EONHL1-20

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅