A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of AZD0486, a Bispecific Antibody Targeting CD19 in Subjects With B-Cell Non-Hodgkin Lymphoma
AstraZeneca
Summary
This phase 1 study will investigate the safety, tolerability, pharmacokinetic, pharmacodynamic, and clinical activity of AZD0486, a CD19 x CD3 T-cell engaging bispecific antibody, in subjects with B-cell non-Hodgkin lymphoma (B-NHL).
Description
This dose escalation and optimization study, is evaluating the safety, tolerability, PK, PD and clinical activity of AZD0486 monotherapy.
Eligibility
- Age range
- 18–130 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Biopsy proven B-NHL, including DLBCL, HGBL, or FL. * Relapsed/refractory cohorts: In order to be eligible subjects must have received at least 2 prior lines of therapy and not be candidates for treatment regimens known to provide clinical benefit in B-NHL. CAR T-naive subjects are allowed if they have declined, are considered ineligible for, or do not have timely access to CAR T cell therapies. * 1L FL cohorts: Subject has biopsy-proven FL Grade 1-3a per WHO 2016 classification, Stage II-IV, FL International Prognostic Index 2-5 that has not been treated with prior sys…
Interventions
- DrugAZD0486 IV
AZD0486 is a bispecific antibody targeting CD19 on tumor cells and CD3 on T-cells leading to T cell-mediated cytotoxicity of malignant B cells
Locations (27)
- Research SiteTampa, Florida
- Research SiteLouisville, Kentucky
- Research SiteNew Brunswick, New Jersey
- Research SiteCharlotte, North Carolina
- Research SiteColumbus, Ohio
- Research SitePortland, Oregon