RecruitingPhase 1NCT04594642

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


Sponsor

AstraZeneca

Enrollment

227 participants

Start Date

Mar 2, 2021

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 130 Years

Plain Language Summary

Simplified for easier understanding

This study tests AZD0486 — a new type of targeted therapy that brings immune T-cells close to cancer cells — in people with B-cell non-Hodgkin lymphoma (a type of blood cancer), either as a single treatment or combined with other agents. It includes groups for relapsed/refractory disease and newly diagnosed follicular lymphoma. **You may be eligible if...** - You have biopsy-proven B-cell non-Hodgkin lymphoma (including DLBCL, HGBL, or follicular lymphoma) - For relapsed/refractory disease: you have received at least 2 prior treatments and are not eligible for or have declined other options like CAR-T therapy - For newly diagnosed follicular lymphoma: your cancer is Stage II–IV and meets criteria requiring treatment - Your liver, kidneys, and bone marrow function are adequate - You have at least one measurable area of cancer **You may NOT be eligible if...** - Your cancer is CD19-negative (the target the drug uses) - Your overall health status is too poor (ECOG score greater than 2) - Your kidney function is significantly reduced Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Site

Tampa, Florida, United States

Research Site

Louisville, Kentucky, United States

Research Site

New Brunswick, New Jersey, United States

Research Site

Charlotte, North Carolina, United States

Research Site

Columbus, Ohio, United States

Research Site

Portland, Oregon, United States

Research Site

Pittsburgh, Pennsylvania, United States

Research Site

Austin, Texas, United States

Research Site

Houston, Texas, United States

Research Site

Milwaukee, Wisconsin, United States

Research Site

Bedford Park, Australia

Research Site

Heidelberg, Australia

Research Site

Hobart, Australia

Research Site

Melbourne, Australia

Research Site

Chūōku, Japan

Research Site

Kōtoku, Japan

Research Site

Nagoya, Japan

Research Site

Yamagata, Japan

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Kaohsiung City, Taiwan

Research Site

Kweishan, Taiwan

Research Site

Tainan, Taiwan

Research Site

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT04594642


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