Trials / Recruiting
RecruitingNCT04594642
A Study of AZD0486 in Subjects With B-Cell Non-Hodgkin Lymphoma
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 317 (estimated)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 130 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
This dose escalation and optimization study, is evaluating the safety, tolerability, PK, PD and clinical activity of AZD0486 monotherapy.
Conditions
- B-cell Non Hodgkin Lymphoma
- Diffuse Large B Cell Lymphoma
- High-grade B-cell Lymphoma
- Follicular Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AZD0486 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 |
Timeline
- Start date
- 2021-03-02
- Primary completion
- 2028-04-19
- Completion
- 2028-04-19
- First posted
- 2020-10-20
- Last updated
- 2026-03-18
Locations
27 sites across 5 countries: United States, Australia, Japan, South Korea, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04594642. Inclusion in this directory is not an endorsement.