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A drug, PIT565, to treat B-cell acute lymphoblastic leukemia (B-ALL) or B-cell non-Hodgkin lymphoma (B-NHL) that has come back (relapsed) or not gotten better with treatment (refractory)

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Phase 1

5 Locations

NCT05397496

Clinical Trial Goal


To find out:
  • The highest dose of PIT565 that's safe to give
  • If PIT565 is safe and works well to treat B-ALL or B-NHL that has relapsed or is refractory

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have one of the following that has relapsed or is refractory:
    • B-ALL
    • B-NHL. Some examples include:
      • Burkitt lymphoma 
      • Chronic lymphocytic leukemia/small-cell lymphocytic lymphoma (CLL/SLL)
      • Diffuse large B-cell lymphoma (DLBCL)
      • Follicular lymphoma
      • Lymphoblastic lymphoma 
      • Mantle cell lymphoma (MCL)
      • Marginal zone lymphoma (MZL)
      • Primary Mediastinal large B-cell lymphoma (PMBCL)
      • Waldenström macroglobulinemia 
  • Do not have lymphoma in your brain or spinal cord
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


PIT565 is a tri-specific antibody that targets CD19, CD3 and CD2 in certain cells. 

You’ll get treatment in cycles that last 1 month. In each cycle, you'll get: 
  • PIT565 – Given as a shot under your skin. The dose you'll get depends on when you start the trial and how safe it has been

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

The Food and Drug Administration (FDA) has not yet approved PIT565. 

Contacts


Novartis Pharmaceuticals, 1-888-669-6682, novartis.email@novartis.com

Novartis Pharmaceuticals, +41613241111, novartis.email@novartis.com

Locations

University Of MiamiRECRUITING

Miami, Florida
German Orellana, 305-243-6823, gdo11@med.miami.edu

University of Chicago Medical CenterRECRUITING

Chicago, Illinois
Anto Jean Xavior, 773-834-2487, antojean.xavior@bsd.uchicago.edu

The University of Kansas Clinical Research CtrRECRUITING

Fairway, Kansas
Ashley Tranckino, atranckino@kumc.edu

Memorial Sloan Kettering Cancer CtrRECRUITING

New York, New York
Grace Cappadona, +1 212 639 3112, cappadog@mskcc.org

Oregon Health Sciences UniversityRECRUITING

Portland, Oregon
Katie Kennedy, 503-494-8311, kennkath@ohsu.edu

ClinicalTrials.gov record


NCT05397496. First posted on 5/31/22

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