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A drug, glofitamab, in combination with lenalidomide and obinutuzumab, to treat mantle cell lymphoma (MCL) that has come back (relapsed) or not gotten better with treatment (refractory)

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18 and older

Phase 1

10 Locations

NCT06192888

Clinical Trial Goal


To find out:
  • The highest dose of glofitamab that's safe to give with lenalidomide and obinutuzumab
  • If the combination of glofitamab, lenalidomide and obinutuzumab is safe and works well to treat MCL that has relapsed or is refractory

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have MCL that has relapsed or is refractory
  • Have cancer cells with mutation/marker CD20. Your doctor can tell you this
  • Have not been treated with a drug that targets CD3 and CD20. Your doctor can tell you this
  • Have not been treated with lenalidomide or other immunomodulatory drugs in the last 1 year
  • Have not had allogeneic (cells from a donor) or autologous (your own cells) blood or marrow transplant (BMT) in the last 3 months
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


Glofitamab is a bispecific monoclonal antibody that targets CD 3 and CD20 on certain cells.
Lenalidomide is a drug that blocks growth of cancer cells.
Obinutuzumab is a monoclonal antibody that targets CD20 on certain cells.
 
You’ll get treatment in cycles that last 1 month. In each cycle, you'll get: 
  • Glofitamab – Given as intravenous (IV) infusions. The dose you'll get depends on when you start the trial and how safe it has been
  • Lenalidomide – 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
  • Obinutuzumab – Given as IV infusions. The dose you'll get depends on when you start the trial and how safe it has been 

You'll have scans to see how well the treatment is working. The clinical trial doctors will check your health for up to 1 year.

The Food and Drug Administration (FDA) has approved all of the drugs used in this trial. Using them in this way to treat MCL that has relapsed or is refractory is new and unproven.

Contacts


Anita Kumar, MD, 646-608-3780, kumara2@mskcc.org

Gilles Salles, MD, PhD, 646-608-4153, SallesG@mskcc.org

Locations

Dana Farber Cancer Institute (Data Collection and Specimen Analysis)RECRUITING

Boston, Massachusetts
Christine Ryan, MD, 617-632-6844

Mayo Clinic (Data Collection Only)RECRUITING

Rochester, Minnesota
Yucai Wang, MD, 507-284-2511

Washington University (Data Collection Only)RECRUITING

St Louis, Missouri
Dilan Patel, MD, 314-747-8173

Memorial Sloan Kettering Bergen (Limited Protocol Activities)RECRUITING

Montvale, New Jersey
Anita Kumar, MD, 646-608-3780

Memorial Sloan Kettering Cancer Center at Basking Ridge (Limited Protocol Activities)RECRUITING

Basking Ridge, New Jersey
Anita Kumar, MD, 646-608-3780

Memorial Sloan Kettering Monmouth (Limited protocol activities)RECRUITING

Middletown, New Jersey
Anita Kumar, MD, 646-608-3780

Memorial Sloan Kettering Cancer Center (All Protocol Activities)RECRUITING

New York, New York
Anita Kumar, MD, 646-608-3780

Memorial Sloan Kettering Nassau (All protocol activities)RECRUITING

Rockville Centre, New York
Anita Kumar, MD, 646-608-3780

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)RECRUITING

Commack, New York
Anita Kumar, MD, 646-608-3780

Memorial Sloan Kettering Westchester (Limited protocol activities)RECRUITING

Harrison, New York
Anita Kumar, MD, 646-608-3780

ClinicalTrials.gov record


NCT06192888. First posted on 1/5/24

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