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Monoclonal Antibodies

Epcoritamab for Lymphoma

Phase 2
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with "double-hit" or "triple-hit" DLBCL (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations). Note: Other double-/triple-hit lymphomas are not eligible.
Relapsed or refractory disease and previously treated with at least 2 prior systemic antineoplastic therapies including at least 1 anti-CD20 monoclonal antibody-containing therapy.
Must not have
Central nervous system (CNS) involvement.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is being conducted to assess the safety of epcoritamab in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL) or R/R follicular lymphoma (FL).

Who is the study for?
Adults with relapsed or refractory Diffuse Large B-Cell Lymphoma or Follicular Lymphoma, who have had at least two prior treatments including an anti-CD20 therapy. Participants must have adequate organ function and a performance status showing they can carry out daily activities with ease to moderate difficulty.
What is being tested?
The trial is testing Epcoritamab, an experimental drug for certain aggressive lymphomas. Patients will receive increasing doses of the drug through skin injections in cycles lasting 28 days each, to determine its safety and monitor any adverse effects.
What are the potential side effects?
Specific side effects are not listed but may include reactions at the injection site, general discomfort, changes in blood tests indicating organ function issues, and other symptoms that will be closely monitored by healthcare professionals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lymphoma is classified as 'double-hit' or 'triple-hit' DLBCL.
Select...
My condition has not improved after two cancer treatments, including one with anti-CD20.
Select...
My lymphoma shows up on scans and has at least one large tumor.
Select...
My lymphoma shows on scans with specific size tumors or nodes.
Select...
I am able to get out of my bed or chair and move around.
Select...
I have relapsed or refractory DLBCL or FL with CD20+ B-cells.
Select...
My lymphoma is classified as 'double-hit' or 'triple-hit' DLBCL.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer has spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Experiencing Grade 3 or Higher Cytokine Release Syndrome (CRS) Events
Percentage of Participants Experiencing Grade 3 or Higher Immune Cell-Associated Neurotoxicity Syndrome (ICANS) Events
Percentage of Participants Experiencing Grade 3 or Higher Neurotoxicity (Ntox) Events
Secondary study objectives
Best Overall Response (BOR) Determined by Lugano 2014 Criteria Per Investigator Assessment
CR Determined by Lugano 2014 Criteria Per Investigator Assessment
Diversity Enriched Cohort: Duration of CR (DOCR)
+19 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Main Cohort: Epcoritamab Follicular Lymphoma (FL)Experimental Treatment1 Intervention
Participants with R/R FL will receive SC epcoritamab in 28 day cycles.
Group II: Main Cohort: Epcoritamab Diffuse Large B-Cell Lymphoma (DLBCL)Experimental Treatment1 Intervention
Participants with relapsed or refractory (R/R) DLBCL will receive subcutaneous (SC) epcoritamab in 28 day cycles.
Group III: Diversity Enriched Cohort: Epcoritamab FLExperimental Treatment1 Intervention
Participants with R/R FL will receive SC epcoritamab in 28 day cycles.
Group IV: Diversity Enriched Cohort: Epcoritamab DLBCLExperimental Treatment1 Intervention
Participants with R/R DLBCL will receive SC epcoritamab in 28 day cycles.

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,029 Previous Clinical Trials
521,346 Total Patients Enrolled
GenmabIndustry Sponsor
71 Previous Clinical Trials
14,737 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
450 Previous Clinical Trials
161,832 Total Patients Enrolled

Media Library

Epcoritamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05451810 — Phase 2
Non-Hodgkin's Lymphoma Research Study Groups: Main Cohort: Epcoritamab Diffuse Large B-Cell Lymphoma (DLBCL), Main Cohort: Epcoritamab Follicular Lymphoma (FL), Diversity Enriched Cohort: Epcoritamab DLBCL, Diversity Enriched Cohort: Epcoritamab FL
Non-Hodgkin's Lymphoma Clinical Trial 2023: Epcoritamab Highlights & Side Effects. Trial Name: NCT05451810 — Phase 2
Epcoritamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05451810 — Phase 2
~101 spots leftby Aug 2027
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