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Zanubrutinib in Combination With Odronextamab for the Treatment of Patients With Richter's Transformation

NCT06735664 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-09-16

No results posted yet for this study

Summary

This phase I trial tests the safety and side effects of zanubrutinib in combination with odronextamab and how well it works in treating patients with Richter's transformation. Zanubrutinib, a tyrosine kinase inhibitor, blocks a protein called Bruton tyrosine kinase (BTK), which may help keep cancer cells from growing. Odronextamab is a bispecific monoclonal antibody that can bind to two different antigens at the same time. Odronextamab binds to CD20 found on B-cells (a type of white blood cell) and on many B-cell cancers and to CD3 on T-cells (also a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Giving zanubrutinib in combination with odronextamab may be safe, tolerable and/or effective in treating patients with Richter's transformation.

Conditions

  • Recurrent Transformed Chronic Lymphocytic Leukemia
  • Refractory Transformed Chronic Lymphocytic Leukemia
  • Richter Syndrome
  • Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma

Interventions

PROCEDURE

Biopsy

Undergo ultrasound guided biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Biopsy

Undergo optional bone marrow biopsy

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Echocardiography

Undergo ECHO

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

BIOLOGICAL

Odronextamab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET

PROCEDURE

Ultrasound Imaging

Undergo ultrasound guided biopsy

DRUG

Zanubrutinib

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Alexey V Danilov · City of Hope Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-14
Primary Completion
2027-12-13
Completion
2027-12-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06735664 on ClinicalTrials.gov