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
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Multiple dose of EO2463
D1-21 of 4-weekly cycles
Multiple doses of rituximab
Dana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
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 months
Phase 2: Overall Response Rate
Overall Response Rate According to the Lugano Classification 2014 during EO2463 Monotherapy
Time frame: Up to 24 months
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 months
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 months
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center)
Rochester, New York, United States
RECRUITINGUniversity of Washington-Seattle Cancer Care Alliance
Seattle, Washington, United States
RECRUITINGCHU d'Amiens-Picardie - Hopital SUD
Amiens, France
RECRUITINGUniversity of Bologna
Bologna, Italy
WITHDRAWNIRCCS Policlinico San Matteo Foundation - University of Pavia
Naples, Italy
RECRUITINGIRCCS Policlinico San Matteo Foundation - University of Pavia
Pavia, Italy
RECRUITINGUniversity Hospital Vall d'Hebron, Institute of Oncology
Barcelona, Spain
RECRUITINGClinica Universidad de Navarra
Madrid, Spain
RECRUITING...and 2 more locations