A Novel Vaccine (EO2463) as Monotherapy and in Combination, for Treatment of Patients With Indolent Non-Hodgkin Lymphoma

Overview

About this study

The purpose of this study is to define the recommended dose, safety, tolerability, immunogenicity, and preliminary effectiveness of EO2463 during monotherapy and in combination with lenalidomide and/or rituximab in patients with indolent Non-Hodgkin's Lymphoma (NHL).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria - Cohorts 1 and 4:

  • Patients having relapsed/refractory, biopsy-proven grade 1, 2 or 3A, FL or MZL.
  • ECOG performance status 0 to 2.
  • Have received at least one prior line of treatment.

Inclusion Criteria - Cohort 2:

  • Patients having newlydiagnosed, 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.
  • Patients not be in need of standard of care therapy according to the assessment of the treating physician.
  • 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).

Inclusion Criteria - Cohort 3:

  • Patients having 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 criteria.
  • Patients in need of therapy according to the assessment of the treating physician.

Inclusion Criteria - Cohorts 1-4:

  • Patients with an age ≥ 18 years old.
  • Patients who are human leukocyte antigen (HLA)-A2 positive.
  • 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.
  • Males or non-pregnant, non-lactating, females.
  • Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.
  • Patients having received the information sheet and who have provided written informed consent prior to any study-related procedures.

Exclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria - Cohorts 1 and 4:

  • Patients who have received rituximab or other B cell ablation therapy within 8 weeks of start of study treatment.

Exclusion Criteria - Cohorts 1-4:

  • Patients with abnormal laboratory values.
  • Patients with persistent Grade 3 or 4 toxicities.
  • Uncontrolled central nervous system (CNS) metastasis.
  • Other malignancy or prior malignancy with a disease-free interval of less than 3 years.
  • Patients with clinically significant disease.
  • Patients with suspected autoimmune or active autoimmune disorder or known history of an autoimmune neurologic condition (e.g., Guillain-Barré syndrome).
  • Patients with history of solid organ transplantation or hematopoietic stem cell transplantation.
  • Pregnant and breastfeeding patients.
  • Patients with history or presence of human immunodeficiency virus and/or potentially active hepatitis B virus/hepatitis C virus infection.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jose Villasboas Bisneto, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

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