A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319 Moves Through the Bodies of Adult Participants With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), or Chronic Lymphocytic Leukemia (CLL)

Launched by ABBVIE · Aug 22, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ABBV-319 for adults with certain types of blood cancers, specifically relapsed or refractory diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL). The main goal is to see how safe this treatment is, how it works in the body, and if it helps to reduce the cancer symptoms. The trial is divided into two parts: the first part will find the right dose of ABBV-319 to use, while the second part will assess how well this dose works for participants.

To be eligible for this trial, participants should be adults with a confirmed diagnosis of one of the cancers mentioned above and should have measurable disease that needs treatment. They need to have a good overall health status and meet specific lab criteria. Participants can expect to receive the treatment through an intravenous infusion every 21 days, and they will have regular check-ups at the hospital or clinic to monitor their health, including blood tests and assessments for any side effects. It's important to note that being part of this trial may involve more visits and tests than standard treatment, but it offers an opportunity to access a new therapy that is still being studied.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • For dose escalation (Part 1) only: Participants with documented diagnosis of B-cell malignancies including those with histology based on criteria established by the World Health Organization (WHO), and measurable disease requiring treatment, as per the protocol.
• • For the relapsed or refractory diffuse large b-cell lymphoma (DLBCL), follicular lymphoma (FL), and Chronic lymphocytic leukemia (CLL) dose expansion cohorts (Part 2) only: Participants with documented diagnosis of one of the B-cell malignancies noted in the protocol with histology based on criteria established by the WHO, and measurable disease requiring treatment, as per the protocol.
• • Laboratory values meeting the criteria noted in the protocol.
• • For participants previously treated with a CD19-targeting therapy (eg, CD19 monoclonal antibody) a core or excision tumor biopsy subsequent to the most recent CD19-targeting therapy must be collected.
• • Participant must have measurable disease, as defined by the 2014 Lugano Classification.
• Exclusion Criteria:
• • Known active central nervous system (CNS) disease, or primary CNS lymphoma.
• • Known active infection or clinically significant uncontrolled conditions as per the protocol.
• • Eastern Cooperative Oncology Group (ECOG) performance status \>= 2.