← Back to searchRecruitingRecruiting
A Study of AZD0486 in Subjects With B-Cell Non-Hodgkin Lymphoma
NCT04594642 · AstraZeneca
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this study
This dose escalation and optimization study, is evaluating the safety, tolerability, PK, PD and clinical activity of AZD0486 monotherapy.
Eligibility criteria
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 systemic lymphoma-directed therapy and requires initiation of treatment based on GELF criteria. Radiation to localized disease prior to study entry is allowed if \>14 days from first dose.
* All Cohorts:
Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
* Subject must have adequate liver, bone marrow and kidney function (eGFR ≥ 50 mL/min).
* Subject must have locally confirmed CD19 positivity (must be documented after time of progression from last CD19-targeted therapy, if received)
* Subject must have at least 1 measurable disease site
* Subject must have ANC \>/= 1000/mm3, platelets \>/= 50,000 mm3, hemoglobin \>/= 8.0 g/dL. Transfusion and/or growth factor are allowed but counts must be stable for at least 72 hours afterwards prior to screening
* Subject must have a total bilirubin \<1.5x ULN, AST/ALT \< 3xULN
Exclusion Criteria:
* Subject has been diagnosed with or treated for another malignancy whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen.
* Subject has active central nervous system (CNS) involvement by their B-NHL. --Subjects may be eligible with a distant history of CNS involvement that has been adequately treated with no evidence of recurrence within last 6 months from screening.
* Subject has a history of leukemic presentation of their B-NHL (\>5,000 circulating lymphoma cells/uL in the peripheral blood).
* Subject has history or presence of clinically significant CNS pathology
* Subject has CNS involvement from active or history of autoimmune disease.
* Subject received CD19 CAR T therapy within 3 months prior to first dose.
* Subject experienced Grade ≥ 3 cytokine release syndrome (CRS) following prior T-cell engager (TCE) or CAR T-cell therapy.
* Subject experienced Grade ≥ 2 neurotoxicity/immune effector cell-associated neurotoxicity syndrome (ICANS) following prior TCE or CAR T-cell therapy.
* Subject has received a peripheral autologous stem cell transplant (SCT) within 12 weeks, or an allogeneic SCT within 1 year of the first dose of study drug treatment or has received an SCT and requires ongoing immunosuppressive therapy.
* Subjects with human immunodeficiency virus (HIV) infection, or subjects with chronic or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Subjects with chronic HBV may be enrolled if the HBV viral load is undetectable on suppressive therapy, or if the subject has a documented cure. Subjects with HCV who have a documented cure may be enrolled.
* Subject has a history of major cardiac abnormalities.
* If female, subject must not be pregnant or breastfeeding.
Study design
Enrollment target: 317 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-03-02
Estimated completion: 2028-04-19
Last updated: 2026-03-18
Interventions
Drug: AZD0486 IV
Primary outcomes
- • Incidence of subjects with Dose-limiting toxicities (DLT) (28 days)
- • Incidence of subjects with adverse events (AEs) and/or serious adverse events (SAEs) (From screening until 90 Days after end of treatment)
- • Maximum Observed Serum Concentration of AZD0486 (Cmax) (4 Weeks)
Sponsor
AstraZeneca · industry
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
InvestigatorDavid Sermer, MD · study_director, AstraZeneca
All locations (27)
Research SiteRecruiting
Tampa, Florida, United States
Research SiteRecruiting
Louisville, Kentucky, United States
Research SiteRecruiting
New Brunswick, New Jersey, United States
Research SiteRecruiting
Charlotte, North Carolina, United States
Research SiteRecruiting
Columbus, Ohio, United States
Research SiteWithdrawn
Portland, Oregon, United States
Research SiteRecruiting
Pittsburgh, Pennsylvania, United States
Research SiteRecruiting
Austin, Texas, United States
Research SiteRecruiting
Houston, Texas, United States
Research SiteRecruiting
Milwaukee, Wisconsin, United States
Research SiteWithdrawn
Bedford Park, Australia
Research SiteRecruiting
Heidelberg, Australia
Research SiteRecruiting
Hobart, Australia
Research SiteRecruiting
Melbourne, Australia
Research SiteRecruiting
Chūōku, Japan
Research SiteRecruiting
Kōtoku, Japan
Research SiteRecruiting
Nagoya, Japan
Research SiteRecruiting
Yamagata, Japan
Research SiteRecruiting
Seoul, South Korea
Research SiteRecruiting
Seoul, South Korea
Research SiteRecruiting
Seoul, South Korea
Research SiteRecruiting
Seoul, South Korea
Research SiteRecruiting
Seoul, South Korea
Research SiteRecruiting
Kaohsiung City, Taiwan
Research SiteRecruiting
Kweishan, Taiwan
Research SiteRecruiting
Tainan, Taiwan
Research SiteRecruiting
Taipei, Taiwan