Active — Not RecruitingPhase 1

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

United States, Australia, Japan226 participantsStarted 2021-03-02

Plain-language 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).

Who can participate

Age range

18 Years – 130 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 d…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since AZD0486 is in Phase 1, the main goal is figuring out safe doses and identifying side effects — not yet proving it works — so can you help me understand what that means for my personal risk-benefit balance compared to standard treatments that already have a longer safety record?
2This trial is measuring dose-limiting toxicities and serious adverse events as primary outcomes, which means they're still learning what the boundaries of safe dosing are — what serious side effects have been observed so far in patients taking AZD0486, and how were they managed?
3The trial is listed as 'active not recruiting,' meaning they're no longer enrolling new patients — does that affect whether this treatment could ever be an option for me, or are there related trials studying AZD0486 that I might still be eligible to discuss?
4My diagnosis involves B-cell Non-Hodgkin Lymphoma, but this trial also includes subtypes like Diffuse Large B-Cell Lymphoma, High-grade B-cell Lymphoma, and Follicular Lymphoma — does my specific subtype and stage matter when weighing whether a Phase 1 drug like this makes sense compared to other available options?
5Since the trial is measuring how AZD0486 moves through the body over time, including blood concentration and half-life, does that mean there are frequent blood draws or monitoring visits involved, and how would that fit into my current treatment schedule?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of subjects with Dose-limiting toxicities (DLT)

Timeframe: 28 days

Incidence of subjects with adverse events (AEs) and/or serious adverse events (SAEs)

Timeframe: From screening until 90 Days after end of treatment

Maximum Observed Serum Concentration of AZD0486 (Cmax)

Timeframe: 4 Weeks

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

Timeframe: 4 Weeks

Apparent terminal half-life (t1/2) of AZD0486

Timeframe: From screening until 90 Days after end of treatment

Trial details

NCT IDNCT04594642

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-06-19

View on ClinicalTrials.gov More B-cell Non Hodgkin Lymphoma trials

Who can participate

Age range

18 Years – 130 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence of subjects with Dose-limiting toxicities (DLT)

Timeframe: 28 days

Incidence of subjects with adverse events (AEs) and/or serious adverse events (SAEs)

Timeframe: From screening until 90 Days after end of treatment

Maximum Observed Serum Concentration of AZD0486 (Cmax)

Timeframe: 4 Weeks

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

Timeframe: 4 Weeks

Apparent terminal half-life (t1/2) of AZD0486

Timeframe: From screening until 90 Days after end of treatment