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NCT06735664 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Richter Syndrome and Recurrent Transformed Chronic Lymphocytic Leukemia, sponsored by City of Hope Medical Center.

Recruiting
Registry status
Phase 1
Development phase
23
Enrollment target
1
Study location

NCT06735664: Recruiting Phase 1 study of Richter Syndrome and Recurrent Transformed Chronic Lymphocytic Leukemia, sponsored by City of Hope Medical Center.

NCT06735664 is a Phase 1 study of Richter Syndrome and Recurrent Transformed Chronic Lymphocytic Leukemia that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 23 participants, below the 30-participant average among 12 other Richter Syndrome trials with a reported enrollment target (23% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06735664, a Phase 1 study of Richter Syndrome and Recurrent Transformed Chronic Lymphocytic Leukemia, is actively recruiting participants, sponsored by City of Hope Medical Center.

RECRUITING
Registry status
Phase 1
Development phase
23 participants
Enrollment target
1
Study location

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.

Primary Outcome

All non-hematologic toxicities will be coded and graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Hematologic toxicities will be assessed per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018. Cytokine release syndrome (CRS)/immune effector cell associated neurotoxicity syndrome (ICANS) will be coded by American Society for Transplantation and Cellular Therapy (ASTCT) grading for CRS/ICANS. DLTs will

Conditions Studied

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

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Bone Marrow Biopsy
  • PROCEDURE Computed Tomography
  • PROCEDURE Biopsy
  • PROCEDURE Echocardiography

Study Locations (1)

California

  • City of Hope Medical Center - Duarte

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2025-08-14
Est. Completion 2027-12-13
Phase Phase 1
City of Hope Medical Center

582 total trials

What NCT06735664 shows while recruiting

NCT06735664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 30-participant average among 12 other Richter Syndrome trials with a reported enrollment target (23% lower).

The record links to 4 conditions, with Richter Syndrome appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT06735664 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT06735664 about?

NCT06735664 is a clinical study titled "Zanubrutinib in Combination With Odronextamab for the Treatment of Patients With Richter's Transformation". 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 ...

What is the current status of trial NCT06735664?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2025-08-14. Estimated completion is 2027-12-13.

What conditions does trial NCT06735664 study?

This clinical trial studies the following conditions: Richter Syndrome, Recurrent Transformed Chronic Lymphocytic Leukemia, Refractory Transformed Chronic Lymphocytic Leukemia, Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma.

What interventions are being tested in trial NCT06735664?

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

Who is sponsoring clinical trial NCT06735664?

This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06735664 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Richter Syndrome

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06735664's enrollment target sits among peer trials

23 9th of 12 higher than 4 of 12 other Richter Syndrome trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Richter Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06735664

Source: ClinicalTrials.gov NCT06735664, the US trial registry maintained by the National Library of Medicine. NCT06735664 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.