New vaccine aims to train immune system against lymphoma
NCT ID NCT04669171
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new vaccine (EO2463) designed to help the immune system fight indolent non-Hodgkin's lymphoma, a slow-growing blood cancer. About 80 adults with follicular or marginal zone lymphoma will receive the vaccine alone or combined with standard drugs lenalidomide and rituximab. The goal is to find the safest and most effective dose.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2021
- Expected to finish
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May 2034
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU d'Amiens-Picardie - Hopital SUD
RECRUITINGAmiens, France
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Clinica Universidad de Navarra
RECRUITINGMadrid, Spain
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Clinica Universidad de Navarra
RECRUITINGPamplona, Spain
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Dana Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
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Hospital Clinico Universitario de Salamanca
RECRUITINGSalamanca, Spain
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IRCCS Policlinico San Matteo Foundation - University of Pavia
RECRUITINGNaples, Italy
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IRCCS Policlinico San Matteo Foundation - University of Pavia
RECRUITINGPavia, Italy
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55905, United States
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University Hospital Vall d'Hebron, Institute of Oncology
RECRUITINGBarcelona, Spain
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University of Bologna
WITHDRAWNBologna, Italy
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University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center)
RECRUITINGRochester, New York, 14642, United States
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University of Washington-Seattle Cancer Care Alliance
RECRUITINGSeattle, Washington, 98109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma
- New drug joins standard chemotherapy in fight against B-Cell lymphoma
- New antibody tested against aggressive blood cancer
- Which lymphoma drug combo works best? a new study aims to find out
- Can engineered immune cells beat tough B-Cell cancers?
- Can a new drug delay the need for lymphoma treatment?