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A Study of AZD0486 for B-Cell Non-Hodgkin Lymphoma

This study is testing a drug called AZD0486 for people with B-cell non-Hodgkin lymphoma (B-NHL), including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), or follicular lymphoma (FL). AZD0486 is a type of targeted therapy that works by helping your body's immune cells (T-cells) fight cancer cells. To join, you must be at least 18 years old and have B-NHL that has come back or not responded to at least two previous treatments. The main goals are to see how safe AZD0486 is, what side effects it might cause, and how much of the drug stays in your body. The study is currently unclear if it is accepting new participants.

Study design
This is a study that will look at the safety and effects of AZD0486 monotherapy. It plans to include 226 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You would be monitored for side effects from screening until 90 days after your last treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04594642

A Study of AZD0486 in Subjects With B-Cell Non-Hodgkin Lymphoma

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
AstraZeneca
~226 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:AZD0486 IV

At a glance

Recruiting sites
0 of 25 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of subjects with Dose-limiting toxicities (DLT)
Measured over 28 days
+4 more outcomes measured

Conditions

B-cell Non Hodgkin Lymphoma
Diffuse Large B Cell Lymphoma
High-grade B-cell Lymphoma
Follicular Lymphoma

Explore related trials

B-Cell Non-Hodgkin LymphomaDiffuse Large B-Cell LymphomaFollicular LymphomaHigh Grade B-Cell Lymphoma

Where it's being run

25 sites across 12 states
South Korea5
Japan4
Taiwan4
Australia3
Texas2
Florida1
Kentucky1
New Jersey1

Study leadership

  • David Sermer, MD · STUDY_DIRECTOR · AstraZeneca

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Biopsy proven B-NHL, including DLBCL, HGBL, or FL.
Relapsed/refractory cohorts:
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 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

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.

What this trial measures

  • Incidence of subjects with Dose-limiting toxicities (DLT)28 days

    A DLT is defined as a TEAE that is not unequivocally due to the subject's underlying malignancy or other extraneous cause. DLT evaluable subjects are defined as those subjects who receive either the target dose of AZD0486 or priming dose(s) in any step-up dose schedule and are assessed for toxicities for the 28-day evaluation period. The NCI-CTCAE version 5.0 will be used (except for CRS and NT). A DLT will be evaluated as Non-hematologic, Hematologic, Cytokine Release Syndrome (CRS), or neurotoxicity.

  • Incidence of subjects with adverse events (AEs) and/or serious adverse events (SAEs)From screening until 90 Days after end of treatment

    The incidence, timing, seriousness, and relationship to study treatment of adverse events will be evaluated.

  • Maximum Observed Serum Concentration of AZD0486 (Cmax)4 Weeks

    The maximum observed serum concentration on a concentration time curve.

  • Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast)4 Weeks

    Area under the serum concentration-time curve from time zero to time of last measurable concentration.

  • Apparent terminal half-life (t1/2) of AZD0486From screening until 90 Days after end of treatment

    Terminal half-life (t1/2,) will be determined after infusion in Cycle 1 using non-compartmental methods.