Epcoritamab Plus Ibrutinib for the Treatment of Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Yazeed Sawalha
Study ID
NCT06536049
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Recurrent Diffuse Large B-Cell Lymphoma
  • Recurrent Grade 3b Follicular Lymphoma
  • Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
  • Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
  • Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified
  • Recurrent Primary Mediastinal Large B-Cell Lymphoma
  • Recurrent Transformed Non-Hodgkin Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma
  • Refractory Grade 3b Follicular Lymphoma
  • Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
  • Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
  • Refractory High Grade B-Cell Lymphoma, Not Otherwise Specified
  • Refractory Primary Mediastinal Large B-Cell Lymphoma
  • Refractory Transformed Non-Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Computed Tomography — PROCEDURE
    Undergo CT and PET/CT
  • Epcoritamab — BIOLOGICAL
    Given SC
  • Ibrutinib — DRUG
    Given PO
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT

Study Details

This phase Ib/II trial evaluates the safety, optimal dose, and efficacy of the combination of epcoritamab and ibrutinib in treating patients with aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or responded to previous treatment (refractory). Epcoritamab, a bispecific antibody, binds to two different types of receptors (proteins present on the cell surface) at the same time. The two receptors that epcoritamab binds to are called CD3 and CD20. CD3 is found on T cells, which are important cells of the immune system that help fight cancer and infections. CD20 is found on the surface of most types of aggressive B-cell non-Hodgkin lymphoma cells. By binding to both CD3 and CD20, epcoritamab brings the two cells close together so the T cells can fight and kill the lymphoma B cells. Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, binds to a protein on B cells, a type of white blood cell from which the lymphoma developed. By doing this it decreases the ability of the lymphoma B cells to survive and grow. Ibrutinib may also improve the health (or fitness) of T cells thus making epcoritamab safer and/or more effective.

Key Dates

Start date
Apr 2, 2025
Status verified
Jun 2026
Primary completion
Aug 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (epcoritamab, ibrutinib)
    Patients receive ibrutinib PO QD on days -7 to 28 of cycle 1 and on days 1 to 28 of remaining cycles, as well as epcoritamab SC on days 1, 8, 15 and 22 of cycles 1-3, days 1 and 15 of cycles 4-9, and on day 1 of remaining cycles. Treatment repeats every 28 days for up to 6 cycles of ibrutinib and up to 12 cycles of epcoritamab in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT and PET/CT throughout the study. Patients may also undergo bone marrow aspiration and biopsy on study.

Primary Outcome Measure

Incidence of adverse events (AEs) [ Time Frame: Up to 60 days after last dose of study drug ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Minnesota/Masonic Cancer CenterMinneapolisMinnesota55455
Marie Hu (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Yazeed Sawalha
[email protected]
614-293-0837
Yazeed Sawalha (PRINCIPAL_INVESTIGATOR)

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By research site
University of Minnesota/Masonic Cancer Center· Minneapolis, MNOhio State University Comprehensive Cancer Center· Columbus, OH

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