RecruitingPhase 2NCT07108998

Study of Epcoritamab as a Consolidation Therapy in CLL/SLL

A Phase 2 Study of Epcoritamab as a Consolidation Therapy for 2nd Generation BTKi +/- Obinutuzumab in CLL/SLL Patients or Variants of This.


Sponsor

Zulfa Omer

Enrollment

22 participants

Start Date

Aug 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase 2 study of Epcoritamab as a consolidation therapy for 2nd generation BTKi +/- Obinutuzumab in CLL/SLL patients or patients with variants of this.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing epcoritamab — an immunotherapy drug that helps the immune system target cancer cells — as a consolidation treatment (given after initial treatment to keep the cancer away) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). **You may be eligible if:** - You have been diagnosed with CLL or SLL - You received a second-generation BTK inhibitor (acalabrutinib or zanubrutinib), with or without obinutuzumab, for at least 12 months as your first treatment - You achieved at least a partial response to that treatment - You meet established diagnostic criteria for CLL/SLL **You may NOT be eligible if:** - You have not completed at least 12 months of first-line BTK inhibitor therapy - Your disease did not respond to prior treatment - You have significant health conditions that would make this treatment unsafe 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

DRUGEpcoritamab

Epcoritamab is the investigational product under study in combination with SOC drugs in this protocol. During C1, epcoritamab will be initiated using step-up dosing (SUD) C1D1 .16mg, C1D8 .8mg, C1D15 3 mg, C1D22 24 mg vs 48 mg (full dose) during safety lead in to determine the RP2D. On Cycles 2-3 the RP2D (24mg vs 48 mg) will be administered on Days 1, 8, 15, 22. Then Cycles 4-9 RP2D will be administered on Days 1 \& 15. Then Cycle 10-12 RP2D on Day 1 of each cycle. Epcoritamab is administered subcutaneously. The SOC BTKi are oral medications administered daily during the trial period.


Locations(1)

University of Cincinnati

Cincinnati, Ohio, United States

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NCT07108998


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