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

Last updated: January 7, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

1

Condition

Follicular Lymphoma

Lymphoma, B-cell

Lymphoma

Treatment

AZD0486 IV

Clinical Study ID

NCT04594642
D7400C00006
  • Ages 18-130
  • All Genders

Study 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 relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) who have received 2 or more prior lines of therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Biopsy proven B-NHL, including DLBCL, HGBL, or FL.

-. In order to be eligible for this study subjects must not be candidates fortreatment regimens known to provide clinical benefit in B-NHL. CAR T-naive subjectsare allowed if they have declined, are considered ineligible for, or do not havetimely access to CAR T cell therapies.

  • Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.

  • Subject must have adequate liver, bone marrow and kidney function (eGFR ≥ 50mL/min).

  • Subject must have locally confirmed CD19 positivity (must be documented after timeof 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 >/= 8.0g/dL. Transfusion and/or growth factor are allowed but counts must be stable for atleast 72 hours afterwards prior to screening

  • Subject must have a total bilirubin <1.5x ULN, AST/ALT < 3xULN

Exclusion

Exclusion Criteria:

  • Subject has been diagnosed with or treated for another malignancy whose naturalhistory or treatment may interfere with the safety or efficacy assessment of theinvestigational regimen.

  • Subject has active central nervous system (CNS) involvement by their B-NHL. Subjectsmay be eligible with a distant history of CNS involvement that has been adequatelytreated with no evidence of recurrence within last 6 months from screening.

  • Subject has a history of leukemic presentation of their B-NHL.

  • 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-cellengager (TCE) or CAR T-cell therapy.

  • Subject experienced Grade ≥ 2 neurotoxicity/immune effector cell-associatedneurotoxicity syndrome (ICANS) following prior TCE or CAR T-cell therapy.

  • Subject has received a peripheral autologous stem cell transplant (SCT) within 12weeks, or an allogeneic SCT within 1 year of the first dose of study drug treatmentor has received an SCT and requires ongoing immunosuppressive therapy.

  • Subjects with human immunodeficiency virus (HIV) infection, or subjects with chronicor active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).HIV-infected patients on effective anti-retroviral therapy with undetectable viralload within 6 months are eligible for this trial. Subjects with chronic HBV may beenrolled if the HBV viral load is undetectable on suppressive therapy, or if thesubject has a documented cure. Subjects with HCV who have a documented cure may beenrolled.

  • Subject has a history of major cardiac abnormalities.

  • If female, subject must not be pregnant or breastfeeding.

Study Design

Total Participants: 231
Treatment Group(s): 1
Primary Treatment: AZD0486 IV
Phase: 1
Study Start date:
March 02, 2021
Estimated Completion Date:
January 15, 2027

Study Description

This dose escalation and optimization study, is evaluating the safety, tolerability, PK, PD and clinical activity of AZD0486 monotherapy.

Connect with a study center

  • Research Site

    Bedford Park, 5042
    Australia

    Site Not Available

  • Research Site

    Heidelberg, 3084
    Australia

    Active - Recruiting

  • Research Site

    Hobart, 7000
    Australia

    Active - Recruiting

  • Research Site

    Melbourne, 3004
    Australia

    Active - Recruiting

  • Research Site

    Chuo-ku, 104-0045
    Japan

    Active - Recruiting

  • Research Site

    Koto-ku, 135-8550
    Japan

    Active - Recruiting

  • Research Site

    Nagoya-shi, 460-0001
    Japan

    Active - Recruiting

  • Research Site

    Yamagata-shi, 990-9585
    Japan

    Active - Recruiting

  • Asan Medical Center

    Seoul, 5505
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Seoul St Mary's Hospital

    Seoul, 6591
    Korea, Republic of

    Active - Recruiting

  • Severance hospital, Yonsei University

    Seoul, 3722
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Kaohsiung City, 833401
    Taiwan

    Active - Recruiting

  • Research Site

    Kweishan, 333
    Taiwan

    Active - Recruiting

  • Research Site

    Tainan, 704
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Research Site

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky 40207
    United States

    Active - Recruiting

  • Research Site

    Louisville, Kentucky 40207
    United States

    Active - Recruiting

  • Research Site

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Levine Cancer Institute/Atrium Health Charlotte NC

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Research Site

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Research Site

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Research Site

    Portland, Oregon 97239
    United States

    Site Not Available

  • Research Site

    Pittsburgh, Pennsylvania 15237
    United States

    Active - Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • Research Site

    Austin, Texas 78704
    United States

    Active - Recruiting

  • Research Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

  • Research Site

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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