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NOT YET RECRUITING
NCT07887061
PHASE2

Tacabrutideg and Sonrotoclax, With Response-Guided Obinutuzumab, for the Treatment of Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Sponsor: Fred Hutchinson Cancer Center

View on ClinicalTrials.gov

Summary

This phase II trial tests how well tacabrutideg and sonrotoclax, with response-guided addition of obinutuzumab, works in treating patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Tacabrutideg is a drug that degrades a protein called Bruton's tyrosine kinase (BTK). By degrading BTK, tacabrutideg inhibits the activation of signaling pathways that help cancer cells survive, inhibiting the growth of cancer cells that express the BTK protein. Sonrotoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving tacabrutideg together with sonrotoclax may kill more cancer cells than giving either drug alone, and giving obinutuzumab after initial treatment with tacabrutideg and sonrotoclax may improve disease response in patients whose CLL or SLL didn't respond completely to initial treatment.

Official title: Phase 2 Study of Time-Limited BGB-16673 and Sonrotoclax With MRD-Guided Addition of Obinutuzumab for Treatment-Naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2027-01-01

Completion Date

2032-07-01

Last Updated

2026-10-21

Healthy Volunteers

No

Interventions

DRUG

Tacabrutideg

Given PO

DRUG

Sonrotoclax

Given PO

BIOLOGICAL

Obinutuzumab

Given IV

PROCEDURE

Transthoracic Echocardiography Test

Undergo TTE

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States