A Novel Vaccine (EO2463) as Monotherapy and in Combination, for Treatment of Patients With Indolent Non-Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEnterome
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
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.
Patients with an age ≥ 18 years old.
Disqualifiers
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.
Patients with grade 3B FL or transformation to an aggressive lymphoma subtype.
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).
Patients with prior exposure to EO2463.
Trial design
Design model
Sequential
Treatments tested in this trial
EO2463
Biological/VaccineMultiple dose of EO2463
lenalidomide
DrugD1-21 of 4-weekly cycles
rituximab
Biological/VaccineMultiple doses of rituximab
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: Cohort 1Experimental treatment 3 interventions
Group B: Cohort 2Experimental treatment 1 intervention
Group C: Cohort 3Experimental treatment 2 interventions
Group D: Cohort 4Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Phase 1: Recommended Phase 2 Dose | Adverse Events Assessment |
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.
Time frame
Up to 24 months2
Phase 2: Overall Response Rate
Overall Response Rate According to the Lugano Classification 2014 during EO2463 Monotherapy
Time frame
Up to 24 months3
Phase 2: Complete Response Rate
Complete remission (CR)-rate according to the Lugano Classification 2014 during therapy with the combination of EO2463/lenalidomide/rituximab.
Time frame
Up to 24 monthsSecondary outcomes
1
Assessment of the Immunogenicity in Relation to OMP72, OMP64, OMP65, OMP66, and UCP2 that Compose EO2463
Immunogenicity will be assessed by interferon-Gamma (IFN-Γ) enzyme-Linked immunospot , and/or by intracellular cytokines staining, and/or multimers staining assays.
Time frame
Up to 24 months2
Evaluation of Overall Survival
The time interval from the date of first study treatment administration to the date of death due to any cause
Time frame
Up to 7 years after last patient enrolled Source ClinicalTrials.gov