NCT07108998 - Study of Epcoritamab as a Consolidation Therapy in CLL/SLL | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 1, 2025

Primary Completion Date

July 1, 2027

Study Completion Date

July 1, 2029

Conditions

CLL/SLLCLLSLLChronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaSmall Lymphocytic Lymphoma VariantChronic Lymphocytic Leukemia Variants

Interventions

DRUG

Epcoritamab

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.

Trial Locations (1)

45219

University of Cincinnati, Cincinnati