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

What this Trial Is About

This research aims to study ABBV-319, an investigational drug, in adults with relapsed or refractory B-cell cancers including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL). These cancers affect immune and blood cells and can be aggressive or slow-growing. The study is designed to evaluate the safety, tolerability, how the drug moves through the body, and early signs of treatment effect in these patients. Participants will receive ABBV-319 through intravenous infusion in cycles lasting 21 days. The study has a dose escalation phase where doses are gradually increased to find the best dose, followed by a dose expansion phase where participants receive the selected dose. Different groups include those with DLBCL, FL, or CLL, all receiving the drug in similar 21-day cycles. The trial may require more visits and procedures than standard care. During the study, participants will attend regular visits for medical assessments, blood tests, questionnaires, and monitoring for side effects. Researchers will track adverse events, drug levels in the blood, immune responses, and disease activity changes. Outcome measures include toxicity, drug concentration, response to treatment, and survival over periods up to 30 months. Participants remain under close medical supervision throughout the trial.

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)