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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Enterome
Study ID
NCT04669171
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EO2463 — BIOLOGICAL
    Multiple dose of EO2463
  • lenalidomide — DRUG
    D1-21 of 4-weekly cycles
  • rituximab — BIOLOGICAL
    Multiple doses of rituximab

Study Details

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

Key Dates

Start date
Jul 5, 2021
Status verified
Jan 2026
Primary completion
May 30, 2029
Completion
May 30, 2034

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Safety Lead-In, Dose-Finding, Cohort, with a 3-by-3 design of EO2463 monotherapy for 6 weeks followed by addition of lenalidomide. Then, if applicable rituximab (depending on response with EO2463 + lenalidomide) will be added. Four to 18 previously treated patients with Follicular Lymphoma (FL) or Marginal Zone Lymphoma (MZL) were anticipated to be included based on safety findings.
  • Experimental: Cohort 2
    Anticipated approximatively 25 previously untreated patients with FL or MZL with an evaluation of EO2463 monotherapy (at the established dose in Cohort 1).
  • Experimental: Cohort 3
    Anticipated approximatively 6 previously untreated patients with FL or MZL with an evaluation of EO2463 (at the established dose in cohort 1) as monotherapy for 6 weeks followed by addition of rituximab if applicable (depending on response with EO2463 monotherapy).
  • Experimental: Cohort 4
    Anticipated approximatively 40 patients previously treated patients with FL (or MZL). Evaluation of EO2463 (at the established dose in Cohort 1) in combination with lenalidomide from day 1 and then with addition of rituximab.

Primary Outcome Measure

Phase 1: Recommended Phase 2 Dose | Adverse Events Assessment | [ Time Frame: Up to 24 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215
Reid Merryman, Dr
Mayo ClinicRochesterMinnesota55905
Jose Caetano Villasboas Bisneto, Dr
University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center)RochesterNew York14642
Danielle Wallace, Dr
University of Washington-Seattle Cancer Care AllianceSeattleWashington98109
Stephen Smith, Dr

Find similar trials in Boston, MA

By research site
Dana Farber Cancer Institute· Boston, MAMayo Clinic· Rochester, MNUniversity of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center)· Rochester, NYUniversity of Washington-Seattle Cancer Care Alliance· Seattle, WA

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