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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 years after last patient enrolled

Awards & highlights

SIDNEY Trial 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.Check my eligibility

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.See study design

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.

SIDNEY Trial 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 newly diagnosed with FL or MZL, have low tumor burden, need therapy, and can care for myself.

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I am newly diagnosed with FL or MZL, only had radiotherapy, and my doctor agrees I don't need standard care yet.

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My cancer worsened within 24 months of diagnosis, and I've had only one prior treatment.

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I am 18 years old or older.

SIDNEY Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Phase 2: Overall Response Rate

Secondary outcome measures

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

SIDNEY 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 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

EnteromeLead Sponsor

8 Previous Clinical Trials

493 Total Patients Enrolled

Jan Fagerberg, MDStudy DirectorEnterome

1 Previous Clinical Trials

1 Total Patients Enrolled

Media Library

EO2463 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04669171 — Phase 1 & 2

Follicular Lymphoma Research Study Groups: Cohort 2, Cohort 3, Cohort 4, Cohort 1

Follicular Lymphoma Clinical Trial 2023: EO2463 Highlights & Side Effects. Trial Name: NCT04669171 — Phase 1 & 2

EO2463 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04669171 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have signed up for the research thus far?

"This clinical trial requires 60 individuals meeting the necessary eligibility criteria. Patients may enroll out of either University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) in Rochester, NY or Dana Farber Cancer Institute located in Boston, MA."

Answered by AI

Is entry into this experiment open to prospective participants?

"Yes indeed. According to information held on clinicaltrials.gov, this trial initiated recruitment June 5th 2021 and is actively seeking out participants as recently as July 26th 2022. The team seeks 60 volunteers across 4 medical sites."

Answered by AI

Has EO2463 yielded any noteworthy outcomes in prior research?

"Initially, EO2463 was studied in 1993 at the National Institutes of Health Clinical Centre on Rockville Pike. Since then there have been 1105 completed studies and 609 ongoing trials--many of which are being conducted in Rochester, New york."

Answered by AI

To which ailments is EO2463 commonly administered?

"EO2463 is often prescribed to treat diffuse large b-cell lymphoma (dlbcl). Additionally, there may be some efficacy in treating conditions such as prior systemic chemotherapy regimens, B-cell lymphomas and polyangium."

Answered by AI

What is the primary objective of this clinical research?

"This trial will assess the efficacy of this medication over a 24 month period, with its primary outcome being Phase 1: Recommended Phase 2 Dose | Adverse Events Assessment. Additionally, researchers will be recording Secondary Outcomes such as Overall Response Rate and Safety & Tolerability for EO2463 Administered Monotherapy or in Combination with Lenalidomide/Rituximab. Lastly, the Duration of Response is also documented by both Lugano Classification 2014 and Lymphoma Response to Immunomodulatory Therapy Criteria (Lyric) 2016 standards."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "A Novel Vaccine (EO2463) as Monotherapy and in Combination, for Treatment of Patients With Indolent Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04669171.

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