Actively Recruiting
A Global Multicenter Phase 1/2 Trial of EO2463, a Novel Microbial-Derived Peptide Therapeutic Vaccine, as Monotherapy, and in Combination With Lenalidomide and Rituximab, for Treatment of Patients With Indolent Non-Hodgkin's Lymphoma
Led by Enterome · Updated on 2026-01-30
80
Participants Needed
12
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating EO2463, a new therapeutic vaccine made from peptides related to tumor and microbiome proteins, in patients with indolent non-Hodgkin lymphoma (NHL). The study aims to find the best dose for Phase 2, assess safety, tolerability, immune response, and early signs of how well the vaccine works alone and combined with lenalidomide and rituximab. This research focuses on patients with follicular lymphoma or marginal zone lymphoma. The study includes several groups: one with EO2463 alone for 6 weeks followed by adding lenalidomide and possibly rituximab based on response; groups with newly diagnosed patients receiving EO2463 alone or with rituximab; and groups with previously treated patients receiving EO2463 combined with lenalidomide and rituximab. Treatments are given in cycles, with doses and combinations adjusted according to patient response and safety findings. Participants will undergo monitoring for up to 24 months to evaluate adverse events, overall and complete response rates, and immune responses related to EO2463 components. Survival will also be tracked for up to 7 years after enrollment. Throughout the study, patients will have scheduled visits, lab tests, and assessments to track safety, immune reactions, and treatment effects, ensuring detailed follow-up and data collection.
CONDITIONS
Brief Title
A Novel Vaccine (EO2463) as Monotherapy and in Combination, for Treatment of Patients With Indolent Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Biopsy-proven grade 1, 2, or 3A follicular lymphoma or marginal zone lymphoma
- ECOG performance status between 0 and 2
- For Cohorts 1 and 4: relapsed or refractory disease with at least one prior treatment
- For Cohort 2: newly diagnosed, previously untreated with low tumor burden and ECOG 0 or 1
- For Cohort 3: newly diagnosed, previously untreated with low tumor burden and need for therapy
- Positive for human leukocyte antigen (HLA)-A2
- Radiologically measurable disease with lymph node or tumor mass ≥ 1.5 cm in one dimension
- Male or non-pregnant, non-lactating female
- Able and willing to comply with study visits, treatment plan, and procedures
- Provided written informed consent prior to study procedures
You will not qualify if you...
- Treatment with dexamethasone > 2 mg/day or equivalent within 14 days before first EO2463 dose unless for adverse event treatment
- Grade 3B follicular lymphoma or transformation to aggressive lymphoma
- Single prior treatment with high-risk profile defined by progression within 24 months (except if more than one prior treatment)
- Prior exposure to EO2463
- Immunotherapy, radionuclide therapy, radiotherapy, cytoreductive therapy, or other investigational agent within 28 days before first EO2463 dose
- Rituximab or B cell ablation therapy within 8 weeks before study start for Cohorts 1 and 4
- Prior CAR T-cell therapy with progression within 6 months for Cohort 4
- Abnormal laboratory values
- Persistent Grade 3 or 4 toxicities
- Uncontrolled central nervous system metastasis
- Other or prior malignancy with less than 3 years disease-free interval
- Clinically significant disease
- Suspected or active autoimmune disorders or history of autoimmune neurologic conditions
- History of solid organ or allogeneic hematopoietic stem cell transplantation
- Pregnant or breastfeeding
- History or presence of HIV or active hepatitis B or C infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive EO2463 vaccine as monotherapy and in combination with lenalidomide and rituximab depending on cohort assignment and response to treatment.
Visits occur regularly during treatment cycles; visit frequency depends on treatment regimen and cohort assignment
Duration - Up to 7 years after last patient enrolled
Participants are monitored for safety, response to treatment, immunogenicity, and overall survival after treatment ends.
Periodic visits for long-term safety and survival assessments
Trial Site Locations
Total: 12 locations
1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
3
University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center)
Rochester, New York, United States, 14642
Actively Recruiting
4
University of Washington-Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Actively Recruiting
5
CHU d'Amiens-Picardie - Hopital SUD
Amiens, France
Actively Recruiting
6
University of Bologna
Bologna, Italy
Withdrawn
7
IRCCS Policlinico San Matteo Foundation - University of Pavia
Naples, Italy
Actively Recruiting
8
IRCCS Policlinico San Matteo Foundation - University of Pavia
Pavia, Italy
Actively Recruiting
9
University Hospital Vall d'Hebron, Institute of Oncology
Barcelona, Spain
Actively Recruiting
10
Clinica Universidad de Navarra
Madrid, Spain
Actively Recruiting
11
Clinica Universidad de Navarra
Pamplona, Spain
Actively Recruiting
12
Hospital Clinico Universitario de Salamanca
Salamanca, Spain
Actively Recruiting
Research Team
J
Jan Fagerberg, MD, PhD
K
Karlijn Kroon, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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