Study on a New Vaccine (EO2463) Alone and with Other Treatments for Indolent Non-Hodgkin Lymphoma

Sponsor: Enterome

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04669171

Provider View

This clinical trial is testing a new vaccine, EO2463, both by itself and in combination with other drugs, to see if it is safe and effective for patients with indolent Non-Hodgkin Lymphoma (NHL).

Patient Parameters

Program Overview

The study aims to find the best dose and evaluate the safety, tolerability, and initial effectiveness of the new vaccine EO2463. This vaccine will be tested alone and with other treatments like lenalidomide and rituximab in patients with indolent Non-Hodgkin Lymphoma (NHL).

Description

EO2463 is a new type of cancer vaccine designed to target specific proteins found in tumors. It will be tested on its own and in combination with other drugs, lenalidomide and rituximab, to gather information on its safety and how well it works in patients with indolent Non-Hodgkin Lymphoma (NHL). The study will help determine the best dose for future research and provide early data on its effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Patients with certain types of indolent Non-Hodgkin Lymphoma (NHL) that have returned or not responded to previous treatments.
  • Patients with newly diagnosed NHL who have not yet received treatment, except for radiotherapy.
  • Patients with only one prior treatment and high-risk disease progression within 24 months of diagnosis.
  • Patients aged 18 years or older.
  • Patients who are HLA-A2 positive.
  • Patients with measurable disease, meaning a tumor or lymph node that is at least 1.5 cm in size.
  • Male or non-pregnant, non-breastfeeding female patients.
  • Patients willing to follow the study schedule and procedures.
  • Patients who have given written consent to participate.

Exclusion Criteria

  • Patients taking high doses of steroids within 14 days before starting the study, unless for treating side effects.
  • Patients with a more aggressive form of lymphoma.
  • Patients with only one prior treatment and high-risk disease progression within 24 months of diagnosis.
  • Patients who have previously received the EO2463 vaccine.
  • Patients who have had certain treatments like immunotherapy or investigational drugs within 28 days before starting the study.
  • Patients who have received rituximab or similar treatments within 8 weeks before starting the study.
  • Patients with abnormal lab results or severe side effects from previous treatments.
  • Patients with uncontrolled cancer spread to the brain.
  • Patients with another cancer or a history of cancer that has not been disease-free for at least 3 years.
  • Patients with significant health issues or autoimmune disorders.
  • Patients with a history of organ or stem cell transplants.
  • Pregnant or breastfeeding patients.
  • Patients with HIV or active hepatitis B or C infections.

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