Epcoritamab as Consolidation Therapy for High-Risk Pts w/CLL on BTKI

NCT07819214 — Phase 2, Not yet recruiting, 24 participants, University of California, Irvine

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Epcoritamab as Consolidation Therapy for High-risk Patients With Chronic Lymphocytic Leukemia on Bruton Tyrosine Kinase Inhibitor

Registry	NCT07819214
Status	Not yet recruiting
Phase	Phase 2
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	24 (Estimated)
Sponsor	University of California, Irvine (Other); collaborators: Genmab
Conditions	CLL, CLL (Chronic Lymphocytic Leukemia), Chronic Lymphocytic Leukemia (CLL), BTKi
Interventions	Epcoritamab (Drug)
Dates	start 2026-10-01 (estimated), primary completion 2028-10-01 (estimated), completion 2032-10-01 (estimated), first posted 2026-09-14, last updated 2026-09-14
Locations	1 site in United States

-Summary

This is a phase 2, single-arm, open-label clinical trial determining efficacy of Epcoritamab in subjects with Chronic Lymphocytic Leukemia (CLL) on Burton Tyrosine Kinase Inhibitor (BTKi).

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+Arms and interventions

Arm	Type	Interventions	Description
Epcoritamab	Experimental	Drug: Epcoritamab	Given IV

Epcoritamab (Drug): Interventional Arm

+Outcome measures

Primary outcomes

Rate of Undetectable Measurable Residual Disease (uMRD) at End of Treatment [1 year]: Efficacy will be determined by rate of uMRD at EOT for both Epcoritamab and BTKi discontinuation

Secondary outcomes

Number of Participants with Complete Remission (CR) by International Workshop on CLL (iwCLL) criteria [1 year]: CR by iwCLL criteria is defined as meeting all parameters which include lymph nodes, liver and/or spleen size, constitutional systems, circulating lymphocyte count, platelet count, hemoglobin, and marrow.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patients with CLL and at least 1 of the following risk factors:

  1. ≥1 prior line of therapy before BTKi
  2. 17p deletion and/or TP53 mutation
  3. Complex karyotype (≥3 chromosomal abnormalities)
* Treated with a BTKi for ≥ 6 months
* Receiving or able to obtain a commercial supply of BTKi
* Measurable residual disease defined as the presence of CLL cells by conventional flow cytometry
* ALC ≤10 K/mcL
* Lymph nodes ≤5 cm in the longest diameter
* Normal organ function and hematologic parameters
* ECOG performance status of 0-1

Exclusion Criteria:

* Active CNS involvement
* Active immune-mediated cytopenias
* Current or prior Richter's transformation
* Second active malignancy requiring treatment (excluding non-melanamatous skin cancers and cancers requiring hormonal therapies alone such as breast/prostate cancer)
* Pregnant or breastfeeding

+Locations (1)

Facility	City	Country	Status
Chao Family Comprehensive Cancer Center, University of California, Irvine	Orange, California	United States

+Investigators

Catherine C Coombs, MD, Principal investigator, Chao Family Comprehensive Cancer Center