eligibility_summary
Eligible: Participants with B‑cell malignancies (Part 1) or R/R DLBCL, FL, or CLL (Part 2) per WHO, with measurable disease per 2014 Lugano and protocol‑specified labs, if previously treated with CD19‑targeting therapy, a post‑therapy tumor biopsy is required. Exclude: active CNS disease/primary CNS lymphoma, active infection/uncontrolled conditions, or ECOG ≥2.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: ABBV-319, an investigational, intravenously infused antibody-based therapy. Mechanism/type: The protocol implies ABBV-319 targets CD19 (post–CD19-therapy biopsy required), consistent with a CD19-directed antibody therapeutic, specific format (monoclonal vs bispecific vs ADC) is not stated. Intended action is binding CD19 on B cells to drive malignant B‑cell elimination via immune effector mechanisms. Targets: CD19-expressing B cells in relapsed/refractory DLBCL, follicular lymphoma, and CLL, pathways associated with B-cell survival/activation (via CD19/B‑cell receptor axis). Design: First-in-human Phase 1, IV dosing in 21-day cycles with dose escalation then expansion to assess safety, PK, and preliminary efficacy in CD19+ B‑cell malignancies.