Actively Recruiting
A Novel Vaccine (EO2463) as Monotherapy and in Combination, for Treatment of Patients With Indolent Non-Hodgkin Lymphoma
Led by Enterome · Updated on 2026-01-30
80
Participants Needed
12
Research Sites
673 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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 with relapsed/refractory, biopsy-proven grade 1, 2, or 3A follicular lymphoma or marginal zone lymphoma with ECOG status 0 to 2, and at least one prior treatment (Cohorts 1 and 4).
- Patients with newly diagnosed, untreated (except prior radiotherapy), biopsy-proven grade 1, 2, or 3A follicular lymphoma or marginal zone lymphoma with ECOG status 0 or 1, low tumor burden, and not needing standard therapy (Cohort 2).
- Patients with newly diagnosed, untreated (except prior radiotherapy), biopsy-proven grade 1, 2, or 3A follicular lymphoma or marginal zone lymphoma with ECOG status 0 or 1, low tumor burden, and needing therapy (Cohort 3).
- Age 18 years or older.
- Human leukocyte antigen (HLA)-A2 positive.
- Radiologically measurable disease with a lymph node or tumor mass at least 1.5 cm in one dimension.
- Male or non-pregnant, non-lactating female.
- Willing and able to comply with visits, treatment, tests, and study procedures.
- Provided written informed consent before study procedures.
You will not qualify if you...
- Use of dexamethasone over 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.
- Only one prior treatment and high-risk profile with disease progression within 24 months of diagnosis (not excluded if more than one prior treatment).
- Prior exposure to EO2463.
- Immunotherapy, radionuclide, radiotherapy, cytoreductive, or investigational treatment within 28 days before first EO2463 dose.
- Rituximab or B cell ablation therapy within 8 weeks before treatment (for Cohorts 1 and 4).
- Prior CAR T-cell therapy with progression within 6 months (for Cohort 4).
- Abnormal lab values or 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 disorder 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
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
CONTACT
K
Karlijn Kroon, MD
CONTACT
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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