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NCT06536049 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, sponsored by Yazeed Sawalha.

Recruiting
Registry status
Phase 1
Development phase
38
Enrollment target
2
Study locations

NCT06536049 is a Phase 1 study of Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma that is actively recruiting participants, run by Yazeed Sawalha. The registered enrollment target is 38 participants, below the 47-participant average among 43 other Recurrent Diffuse Large B-Cell Lymphoma trials with a reported enrollment target (19% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT06536049, a Phase 1 study of Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, is actively recruiting participants, sponsored by Yazeed Sawalha.

RECRUITING
Registry status
Phase 1
Development phase
38 participants
Enrollment target
2
Study locations

Study Summary

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.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Bone Marrow Aspiration
  • PROCEDURE Bone Marrow Biopsy
  • PROCEDURE Computed Tomography
  • BIOLOGICAL Epcoritamab

Study Locations (2)

Minnesota

  • University of Minnesota/Masonic Cancer Center - Minneapolis

Ohio

  • Ohio State University Comprehensive Cancer Center - Columbus

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2025-04-02
Est. Completion 2028-12-31
Phase Phase 1

Sponsor

Yazeed Sawalha

2 total trials

What the Registry Record Tells You About NCT06536049

The ClinicalTrials.gov registry entry for NCT06536049 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 47-participant average among 43 other Recurrent Diffuse Large B-Cell Lymphoma trials with a reported enrollment target (19% lower). The listed sponsor is Yazeed Sawalha, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Recurrent Diffuse Large B-Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT06536049 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Minnesota, Ohio.

Frequently Asked Questions

What is clinical trial NCT06536049 about?

NCT06536049 is a clinical study titled "Epcoritamab Plus Ibrutinib for the Treatment of Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma". 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, ...

What is the current status of trial NCT06536049?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2025-04-02. Estimated completion is 2028-12-31.

What conditions does trial NCT06536049 study?

This clinical trial studies the following conditions: Recurrent Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Recurrent Grade 3b Follicular Lymphoma, Recurrent Transformed Non-Hodgkin Lymphoma, Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements.

What interventions are being tested in trial NCT06536049?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Epcoritamab (BIOLOGICAL).

Who is sponsoring clinical trial NCT06536049?

This trial is sponsored by Yazeed Sawalha, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06536049 being conducted?

This trial has 2 study locations across Minnesota, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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