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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT06735664
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

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

Interventions

  • Biopsy — PROCEDURE
    Undergo ultrasound guided biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Biopsy — PROCEDURE
    Undergo optional bone marrow biopsy
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Echocardiography — PROCEDURE
    Undergo ECHO
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Odronextamab — BIOLOGICAL
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET
  • Ultrasound Imaging — PROCEDURE
    Undergo ultrasound guided biopsy
  • Zanubrutinib — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Aug 14, 2025
Status verified
Sep 2025
Primary completion
Dec 13, 2027
Completion
Dec 13, 2027

Study Design

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

Arms

  • Experimental: Treatment (odronextamab, zanubrutinib)
    Patients receive odronextamab IV over 4 hours on days 1, 2, 8, 9, 15 and 16 of cycle 1 and over 1-4 hours on days 1, 8 and 15 of cycles 2-4 and then on days 1 and 15 of remaining cycles. Patients with CR at cycle 9 may receive odronextamab on day 1 of remaining cycles. Starting with cycle 2, patients also receive zanubrutinib PO QD or BID of each cycle. Cycles repeat every 21 days for cycles 1-4 in the absence of disease progression or unacceptable toxicity then repeat every 28 days for up to cycle 12. After 12 cycles, patients may continue zanubrutinib at investigator's discretion. Patients also undergo ECHO or MUGA and optional bone marrow biopsy at screening and ultrasound guided biopsy of lymph node at screening and during days 2-12 of cycle 2. Additionally, patients undergo blood sample collection and PET, or CT throughout the study.

Primary Outcome Measure

Dose limiting toxicity (DLT) [ Time Frame: During the first 2 cycles of protocol therapy (cycle length = 21 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Alexey V. Danilov
[email protected]
626-218-2405
Alexey V. Danilov (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope Medical Center· Duarte, CA

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