BAF_FRontier-1, A First-in-Human, Phase 1 Trial to Assess Safety, Tolerability, and Preliminary Efficacy of LY4152199, a B-cell Activation Factor Receptor [BAFF-R] T-Cell Engager Bispecific Antibody, in Adult Participants with Previously Treated B-cell Malignancies (NCT07101328)

LY4152199 is a human BAFF-R×CD3 bispecific antibody that engages BAFF-R on the surface of B-cells and CD3 on the surface of T-cells, with the goal of T-cell-mediated elimination of BAFF-R expressing malignant B-cells. Cohort A will assess the safety, tolerability, PK, and preliminary efficacy of escalating doses of LY4152199, administered via intravenous (IV) infusion, in participants with select relapsed/refractory B-cell malignancies. Cohort B will further assess the safety, tolerability, PK, and preliminary efficacy of LY4152199 in participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).

Trial phase

Phase 1

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Constantine Tam

Key inclusion data

Key inclusion criteria include: Participants with DLBCL and FL should have failed or not be eligible for available therapies with established clinical benefit. Must have histologically confirmed relapsed/refractory B-cell malignancy. Eligible malignancies include DLBCL (NOS or transformed from FL) and FL (Grades 1 to 3a). Must have failed or were intolerant to at least 2 prior lines of therapy appropriate for available treatment for the specific B-cell malignancy. Key exclusion criteria Known or suspected CNS involvement by systemic lymphoma Residual symptoms of neurotoxicity or cytopenias from prior CAR-T or bispecifics. Exception: Cytopenia related to prior CAR-T or bispecifics allowed if the participant meets the adequate organ function outlined for the specific cohort in the inclusion criteria.