Follicular Lymphoma, Marginal Zone Lymphoma
Conditions
Keywords
Follicular Lymphoma, Marginal Zone Lymphoma, Rituximab, Lenalidomide, Peptide-based immunotherapy
Brief summary
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
Detailed description
EO2463 Is an innovative cancer peptide therapeutic vaccine based on the homologies between tumor associated antigens and microbiome-derived peptides that will be administered alone and in combination with lenalidomide, rituximab, and lenalidomide/rituximab to generate safety and preliminary efficacy data in patients with indolent NHL
Interventions
BIOLOGICALEO2463
Multiple dose of EO2463
DRUGlenalidomide
D1-21 of 4-weekly cycles
BIOLOGICALrituximab
Multiple doses of rituximab
Sponsors
Enterome
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Recommended Phase 2 Dose | Adverse Events Assessment | | Up to 24 months | 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. |
| Phase 2: Overall Response Rate | Up to 24 months | Overall Response Rate According to the Lugano Classification 2014 during EO2463 Monotherapy |
| Phase 2: Complete Response Rate | Up to 24 months | Complete remission (CR)-rate according to the Lugano Classification 2014 during therapy with the combination of EO2463/lenalidomide/rituximab. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the Immunogenicity in Relation to OMP72, OMP64, OMP65, OMP66, and UCP2 that Compose EO2463 | Up to 24 months | Immunogenicity will be assessed by interferon-Gamma (IFN-Γ) enzyme-Linked immunospot , and/or by intracellular cytokines staining, and/or multimers staining assays. |
| Evaluation of Overall Survival | Up to 7 years after last patient enrolled | The time interval from the date of first study treatment administration to the date of death due to any cause |
Countries
France, Italy, Spain, United States
Contacts
CONTACTJan Fagerberg, MD, PhD
CONTACTKarlijn Kroon, MD
STUDY_DIRECTORJan Fagerberg, MD
Enterome
Outcome results
None listed