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New antibody drug takes aim at Hard-to-Treat lymphoma

NCT ID NCT04594642

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial is testing a new drug called AZD0486 in about 226 people with B-cell non-Hodgkin lymphoma, including types like diffuse large B-cell lymphoma and follicular lymphoma. The drug is a bispecific antibody designed to help the body's immune T-cells recognize and kill cancer cells. The main goals are to check safety, find the right dose, and see early signs of tumor shrinkage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AZD0486 (a bispecific antibody that helps immune cells attack cancer cells)
What this could lead to
If successful, this could lead to a new treatment option for people with B-cell non-Hodgkin lymphoma who have not responded to other therapies.
What could go wrong
This is an early phase 1 trial, so the main goal is safety, not proof of effectiveness. Side effects like cytokine release syndrome and nerve problems are possible, and the drug may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

226 people

The number who actually took part.

Started

Mar 2021

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

B-cell neoplasm B-cell non-Hodgkin lymphoma diffuse large B-cell lymphoma follicular lymphoma high grade B-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

B-cell non Hodgkin lymphoma Diffuse large B cell lymphoma Follicular lymphoma High-grade B-cell lymphoma

Contacts and locations

Locations

  • Research Site

    Tampa, Florida, 33612, United States

  • Research Site

    Louisville, Kentucky, 40207, United States

  • Research Site

    New Brunswick, New Jersey, 08901, United States

  • Research Site

    Charlotte, North Carolina, 28204, United States

  • Research Site

    Columbus, Ohio, 43210, United States

  • Research Site

    Pittsburgh, Pennsylvania, 15237, United States

  • Research Site

    Austin, Texas, 78704, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    Milwaukee, Wisconsin, 53226, United States

  • Research Site

    Heidelberg, 3084, Australia

  • Research Site

    Hobart, 7000, Australia

  • Research Site

    Melbourne, 3004, Australia

  • Research Site

    Chūōku, 104-0045, Japan

  • Research Site

    Kōtoku, 135-8550, Japan

  • Research Site

    Nagoya, 460-0001, Japan

  • Research Site

    Yamagata, 990-9585, Japan

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Seoul, 06591, South Korea

  • Research Site

    Seoul, 120-752, South Korea

  • Research Site

    Kaohsiung City, 833401, Taiwan

  • Research Site

    Kweishan, 333, Taiwan

  • Research Site

    Tainan, 704, Taiwan

  • Research Site

    Taipei, 10002, Taiwan

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