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Cancer Vaccine

EO2463 Combination Therapy for Non-Hodgkin's Lymphoma (SIDNEY Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Enterome

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who are human leukocyte antigen (HLA)-A2 positive.

Males or non-pregnant, non-lactating, females.

Must not have

Patients with prior exposure to EO2463.

Patients with suspected autoimmune or active autoimmune disorder or known history of an autoimmune neurologic condition (e.g. Guillain-Barré syndrome).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 years after last patient enrolled

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Summary

This trial is testing a new drug, EO2463, to see if it is safe and effective in treating patients with indolent non-Hodgkin's lymphoma.

Who is the study for?

Adults over 18 with certain types of indolent Non-Hodgkin Lymphoma (NHL) such as Follicular Lymphoma or Marginal Zone Lymphoma. Participants must have measurable disease, be HLA-A2 positive, and can include both newly diagnosed and those who've relapsed after treatment. Excludes pregnant women, individuals on high-dose steroids, those with aggressive lymphoma subtypes or other recent cancers, uncontrolled brain metastasis, autoimmune disorders, organ transplants, HIV/HBV/HCV infections.

What is being tested?

The trial is testing EO2463 alone and in combination with lenalidomide and/or rituximab to determine the optimal dose for Phase 2 trials. It aims to assess safety, tolerability, immune response generation (immunogenicity), and initial effectiveness against indolent NHL.

What are the potential side effects?

Potential side effects may include reactions at the injection site for EO2463; lenalidomide could cause blood clots or birth defects if taken during pregnancy; rituximab might lead to infusion reactions or infections due to weakened immunity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am HLA-A2 positive.

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I am a male or a female not pregnant or breastfeeding.

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I have a tumor or lymph node that is at least 1.5 cm big.

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I have a certain type of lymphoma, can still care for myself, and have had at least one treatment.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously been treated with EO2463.

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I have or might have an autoimmune disorder, including conditions like Guillain-Barré syndrome.

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I do not have uncontrolled brain metastasis.

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I do not have ongoing severe side effects from previous treatments.

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I have been cancer-free for less than 3 years from a different or prior cancer.

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My lymphoma is grade 3B or has become more aggressive.

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I have had an organ or stem cell transplant.

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I have a history or current infection of HIV, hepatitis B, or hepatitis C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 years after last patient enrolled

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 years after last patient enrolled

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years after last patient enrolled for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1: Recommended Phase 2 Dose | Adverse Events Assessment |

Phase 2: Overall Response Rate

Secondary study objectives

Assessment of the Immunogenicity in Relation to OMP72, OMP64, OMP65, OMP66, and UCP2 that Compose EO2463

Duration of response

Evaluation of Overall Survival

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 4Experimental Treatment3 Interventions

15 Previously treated patients with FL Or MZL. Evaluation of EO2463 at the established dose in Cohort 1 in combination with lenalidomide and with addition of rituximab from week 19 onwards (depending on response)

Group II: Cohort 3Experimental Treatment2 Interventions

15 Previously untreated patients with FL or MZL. Evaluation of EO2463 at the established dose in cohort 1 as monotherapy for 6 weeks and in combination with rituximab from week 7

Group III: Cohort 2Experimental Treatment1 Intervention

15 Previously untreated patients with FL Or MZL. Evaluation of EO2463 monotherapy at the established dose in Cohort 1

Group IV: Cohort 1Experimental Treatment3 Interventions

Safety Lead-In, Dose-Finding, Cohort, with a 3-by-3 design of EO2463 for 6 weeks followed by addition of lenalidomide week 7 and rituximab week 19 (depending on response). Four to 18 evaluable (previously treated) patients with Follicular Lymphoma (FL) or Marginal Zone Lymphoma (MZL) will be Included based on safety findings

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

FDA approved

Rituximab

FDA approved

0 / 13Eligibility criteria met