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A drug, BGB-16673, in combination with other drugs, to treat B-cell leukemia or B-cell lymphoma that has come back (relapsed) or not gotten better with treatment (refractory)

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18 and older

Phase 1, Phase 2

16 Locations

NCT06634589

Clinical Trial Goal


To find out:
  • The highest dose of BGB-16673 that's safe to give 
  • If BGB-16673 in combination with other drugs is safe and works well to treat B-cell leukemia or B-cell lymphoma that has relapsed or is refractory

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have B-cell leukemia or B-cell lymphoma that has relapsed or is refractory
  • Have not had autologous (your own cells) blood or marrow transplant (BMT) in the last 3 months
  • Have not had allogeneic (cells from a donor) BMT 
  • Do not have graft-versus-host-disease (GVHD)
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


BGB-16673 is a Bruton tyrosine kinase degrader that targets BTK in certain cells. 
Glofitamab is a bispecific monoclonal antibody that targets CD3 and CD20 on certain cells.
Mosunetuzumab is a T-cell engaging bispecific antibody that target CD20 and CD3 on certain cells.
Obinutuzumab is a monoclonal antibody that targets CD20 on certain cells.
Sonrotoclax and zanubrutinib are small molecule inhibitors that block BTK in certain cells.

In this trial, you’ll be randomized to 1 of 4 groups. Once you’re randomized, you’ll be told what group you’re in:
  • Group 1 – BGB-16673 plus sonrotoclax
  • Group 2 – BGB-16673 plus zanubrutinib
  • Group 3 - BGB-16673 plus mosunetuzumab
  • Group 4 - BGB-16673 plus glofitamab and obinutuzumab

Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.
 
You’ll get:
  • BGB-16673 – A pill that you take by mouth. The dose you'll get depends on when you start the trial and how safe it has been
  • Glofitamab - Group 4 only - Given as intravenous (IV) infusions
  • Mosunetuzumab - Group 3 only - Given as a shot under your skin
  • Obinutuzumab - Group 4 only - Given as IV infusions
  • Sonrotoclax –  Group 1 only - A pill that you take by mouth. The dose you'll get depends on when you start the trial and how safe it has been
  • Zanubrutinib –  Group 2 only - A pill that you take by mouth. The dose you'll get depends on when you start the trial and how safe it has been

You may continue treatment for up to about 2 years. You'll have biopsies or scans to see how well the treatment is working. The clinical trial doctors will check your health for up to 3 years.

The Food and Drug Administration (FDA) has not yet approved BGB-16673 or sonrotoclax. 

Contacts


Study Director, 1.877.828.5568, clinicaltrials@beonemed.com

Locations

Mayo Clinic PhoenixRECRUITING

Phoenix, Arizona

University of Southern Californianorris ComprehensiveRECRUITING

Los Angeles, California

Mayo Clinic JacksonvilleRECRUITING

Jacksonville, Florida

Moffitt Cancer CenterRECRUITING

Tampa, Florida

The University of Kansas Cancer CenterRECRUITING

Westwood, Kansas

Mayo Clinic RochesterRECRUITING

Rochester, Minnesota

Washington University School of MedicineRECRUITING

St Louis, Missouri

Summit Medical GroupRECRUITING

Florham Park, New Jersey

Icahn School of Medicine At Mount SinaiRECRUITING

New York, New York

Memorial Sloan Kettering Cancer Center MskccRECRUITING

New York, New York

University of RochesterRECRUITING

Rochester, New York

Weill Cornell Medical College Newyork Presbyterian HospitalRECRUITING

New York, New York

Fox Chase Cancer CenterRECRUITING

Philadelphia, Pennsylvania

The University of Texas Md Anderson Cancer CenterRECRUITING

Houston, Texas

Huntsman Cancer InstituteRECRUITING

Salt Lake City, Utah

University of WisconsinRECRUITING

Madison, Wisconsin

ClinicalTrials.gov record


NCT06634589. First posted on 10/10/24

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