A Phase 1 Study of ABBV-319 in People With B-Cell Cancers

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Full Title

Study M22-716: A First-In-Human Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-319 in B-cell Malignancies

Purpose

In this study, researchers want to find the best dose of ABBV-319 to use in people with B-cell cancers. The people in this study have B-cell cancers that keep growing even after treatment. Examples of B-cell cancers treated in this study include:

  • Diffuse large B-cell lymphoma
  • Mantle cell lymphoma
  • Small lymphocytic lymphoma
  • Chronic lymphocytic lymphoma
  • Marginal zone lymphoma
  • Waldenstrom’s macroglobulinemia

ABBV-319 binds to a protein called CD19, which is found on the surface of cancer cells. After binding to CD19, ABBV-319 enters the cancer cells and kills them. It is given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have a B-cell cancer that keeps growing after at least 2 prior regimens of treatment.
  • Have recovered from the serious side effects of previous treatments before getting ABBV-319.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Paola Ghione’s office at 646-608-4263.

Protocol

23-255

Phase

Phase I (phase 1)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05512390