A Novel Vaccine (EO2463) as Monotherapy and in Combination, for Treatment of Patients With Indolent Non-Hodgkin Lymphoma
NCT ID: NCT04669171
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2021-07-05
2032-05-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1
Safety Lead-In, Dose-Finding, Cohort, with a 3-by-3 design of EO2463 for 6 weeks followed by addition of lenalidomide week 7 and rituximab week 19 (depending on response). Four to 18 evaluable (previously treated) patients with Follicular Lymphoma (FL) or Marginal Zone Lymphoma (MZL) will be Included based on safety findings
EO2463
Multiple dose of EO2463
lenalidomide
D1-21 of 4-weekly cycles
rituximab
Multiple doses of rituximab
Cohort 2
15 Previously untreated patients with FL Or MZL. Evaluation of EO2463 monotherapy at the established dose in Cohort 1
EO2463
Multiple dose of EO2463
Cohort 3
15 Previously untreated patients with FL or MZL. Evaluation of EO2463 at the established dose in cohort 1 as monotherapy for 6 weeks and in combination with rituximab from week 7
EO2463
Multiple dose of EO2463
rituximab
Multiple doses of rituximab
Cohort 4
15 Previously treated patients with FL Or MZL. Evaluation of EO2463 at the established dose in Cohort 1 in combination with lenalidomide and with addition of rituximab from week 19 onwards (depending on response)
EO2463
Multiple dose of EO2463
lenalidomide
D1-21 of 4-weekly cycles
rituximab
Multiple doses of rituximab
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
EO2463
Multiple dose of EO2463
lenalidomide
D1-21 of 4-weekly cycles
rituximab
Multiple doses of rituximab
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
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 with abnormal laboratory values.
8. Patients with persistent Grade 3 or 4 toxicities.
9. Uncontrolled central nervous system (CNS) metastasis.
10. Other malignancy or prior malignancy with a disease-free interval of less than 3 years.
11. Patients with clinically significant disease.
12. Patients with suspected autoimmune or active autoimmune disorder or known history of an autoimmune neurologic condition (e.g. Guillain-Barré syndrome).
13. Patients with history of solid organ transplantation or allogeneic hematopoietic stem cell transplantation.
14. Pregnant and breastfeeding patients.
15. Patients with history or presence of human immunodeficiency virus and/or potentially active hepatitis B virus/hepatitis C virus infection.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Enterome
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jan Fagerberg, MD
Role: STUDY_DIRECTOR
Enterome
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center)
Rochester, New York, United States
University of Washington-Seattle Cancer Care Alliance
Seattle, Washington, United States
CHU d'Amiens-Picardie - Hopital SUD
Amiens, , France
University of Bologna
Bologna, , Italy
IRCCS Policlinico San Matteo Foundation - University of Pavia
Naples, , Italy
IRCCS Policlinico San Matteo Foundation - University of Pavia
Pavia, , Italy
University Hospital Vall d'Hebron, Institute of Oncology
Barcelona, , Spain
Clinica Universidad de Navarra
Madrid, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Hospital Clinico Universitario de Salamanca
Salamanca, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Reid Merryman, Dr
Role: primary
Jose Caetano Villasboas Bisneto, Dr
Role: primary
Jonathan Friedberg, Dr
Role: primary
Stephen Smith, Dr
Role: primary
Jean-Pierre Marolleau, Dr
Role: primary
Pier Luigi Zinzani, Dr
Role: primary
Antonio Pinto, Dr
Role: primary
Luca Arcaini, Dr
Role: primary
Francisco Bosch Albareda, Dr
Role: primary
Carlos Grande, Dr
Role: primary
Carlos Grande Garcia, Dr
Role: primary
Norma C Gutierrez, Dr
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EONHL1-20
Identifier Type: -
Identifier Source: org_study_id