RecruitingPhase 2NCT06238648

Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed CAR-T Therapy

Multicenter, Randomized Phase II Study of Epcoritamab for Patients With Aggressive B-Cell Lymphomas Achieving a Partial Response After CD19-Directed CAR-T Therapy


Sponsor

Academic and Community Cancer Research United

Enrollment

120 participants

Start Date

Jan 31, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial compares epcoritamab to standard practice (observation) for the treatment of patients with B-cell lymphomas who are not in complete remission after treatment with CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy. Epcoritamab is a bispecific antibody. It works by simultaneously attaching to a molecule called CD20 on cancerous B-cells and a molecule called CD3 on effector T-cells, which are a type of immune cell. When epcoritamab binds to CD20 and CD3, it brings the two cells together and activates the T-cells to kill the cancerous B-cells. Epcoritamab may increase a patient's chances of achieving complete remission after CD19-directed CAR-T therapy, compared to standard observation.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving a drug called epcoritamab after CAR-T cell therapy can help patients with a type of blood cancer called B-cell lymphoma (specifically diffuse large B-cell lymphoma) who did not achieve a complete response from CAR-T treatment. CAR-T therapy reprograms your own immune cells to fight cancer, but some patients only achieve a partial response — this trial aims to improve outcomes for those patients. **You may be eligible if...** - You are 18 or older - You have been diagnosed with diffuse large B-cell lymphoma or a related B-cell lymphoma with CD20 positivity - You received one of three approved CAR-T therapies (axi-cel, tisa-cel, or liso-cel) - Your PET scan at day 30 after CAR-T showed only a partial response (not full remission) - You have measurable disease remaining - Your general health status is good (ECOG 0, 1, or 2) - Your blood counts meet the required levels **You may NOT be eligible if...** - You achieved a complete response from CAR-T therapy - You have disease that is not measurable - You have poor organ function or very low blood counts Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

PROCEDUREComputed Tomography

Undergo PET/CT and/or CT

BIOLOGICALEpcoritamab

Given SC

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

OTHERPatient Observation

Undergo observation

PROCEDUREPositron Emission Tomography

Undergo PET/CT


Locations(6)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Siteman Cancer Center at Washington University

St Louis, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT06238648


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