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 MalignanciesPurpose
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