Study of Epcoritamab as a Consolidation Therapy in CLL/SLL

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZulfa Omer

About this trial

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 criteria

Qualifiers

Diagnosis of CLL or SLL meeting the established 2018 iwCLL diagnostic criteria or variant of CLL/SLL and has received a 2nd generation BTKi (acalabrutinib or zanubrutinib) +/- obinutuzumab for a minimum of 12 months as first line therapy.

Attainment of Partial Response or greater with a 2nd generation BTKi (acalabrutinib or zanubrutinib) +/- obinutuzumab but detectable disease in blood or bone marrow by NGS ClonoSEQ.

Age ≥18 years.

ECOG performance status ≤2 (or Karnofsky ≥60%, see Appendix D).

Disqualifiers

Obtaining a CR or nodal PR with no detectable disease in blood or bone marrow after treatment with a 2nd generation BTKi (acalabrutinib or zanubrutinib) +/- obinutuzumab as assessed by Adaptive's NGS ClonoSEQ.

Absence of CD20 expression on CLL cells at pre-treatment.

Received any prior treatment ever with a CD3×CD20 bispecific antibody.

Organ transplant recipients are excluded except those with no active graft versus host disease (GVHD) requiring treatment within 12 months of beginning treatment on study.

Trial design

Treatments tested in this trial

  • Epcoritamab

Treatment groups

22 Participants
are divided into 1 treatment group

Sponsors and collaborators

Zulfa Omer

Lead sponsor

University of Cincinnati

Sponsor institution

Genmab

Collaborator