NCT07108998

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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Zulfa Omer · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase II, multicenter trial, where we seek to test the hypothesis that administration of up to 12 cycles of epcoritamab following a 12 months or greater time period of acalabrutinib +/- obinutuzumab or zanubrutinib +/- obinutuzumab in patients who have attained a partial response or better will have a high CR conversion rate with uMRD that enables discontinuation of therapy and lead to durable remission. Additionally, Patients attaining this exceptional uMRD CR at completion of therapy will have evidence of autologous T-cell response toward the patient pre-treatment CLL cells. A safety lead in of the combination for the first 9 patients followed by Simon's 2 stage design will be implemented. Following our inclusion and exclusion criteria, eligible patients will be treated with subcutaneous epcoritamab for a total of 12 cycles while continuing their BTKi therapy. Patients will be assessed for disease response as defined by the iw-CLL 2018 response criteria following completion of cycle 6 and 12 of epcoritamab by peripheral blood labs, CT imaging and bone marrow biopsy for morphology and flow cytometry (if labs/imaging indicating CR) and MRD status through NGS assay (ClonoSEQ). MRD will be performed from bone marrow samples if BMBx is done, and if not done peripheral blood sample will be used for MRD status. All patients who complete 12 cycles of epcoritamab consolidative therapy will have the ability to continue BTKi as monotherapy regardless of MRD status, pending discussion with the patient and treating-physician.

Conditions

• CLL/SLL
• CLL
• SLL
• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma
• Small Lymphocytic Lymphoma Variant
• Chronic Lymphocytic Leukemia Variants

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-22
• Primary completion: 2027-07-01
• Completion: 2029-07-01
• First posted: 2025-08-07
• Last updated: 2026-01-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study