AZD0486 as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL

Last updated: February 11, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

2

Condition

Follicular Lymphoma

Lymphoma, B-cell

Lymphoma

Treatment

AZD0486

Clinical Study ID

NCT06526793
D7404C00001
2023-505789-27-00
  • Ages 18-80
  • All Genders

Study Summary

This is a Phase 2 global, multi-center, open-label study to assess the efficacy, safety and tolerability of AZD0486 monotherapy in adult participants with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) who have received at least two prior lines of therapies. The study has 2 Modules: Module 1 for FL and Module 2 for DLBCL.

Eligibility Criteria

Inclusion

  1. Key Inclusion Criteria:
  • Aged 18 to 80 years old

  • Histologically confirmed relapsed refractory FL (Module 1) and DLBCL (Module 2)after at least 2 prior lines of therapy

  • ECOG performance status 0 to 2

  • Locally confirmed CD-19 expression in lymphoma cells after progression fromlast CD 19 directed therapy

  • FDG-avid disease with at least one bi-dimensionally measurable nodal lesion (defined as > 1.5 cm in its longest dimension), or extranodal lesion (definedas > 1.0 cm in its longest dimension)

  • Adequate hematological function: ANC ≥ 1000/mm3, platelets

  • 75,000/mm3, hemoglobin ≥ 9 g/dL. Transfusion and/or growth factor areallowed but counts must be stable for at least 72 hours afterwards priorto screening

  • Adequate liver function: total bilirubin <1.5x ULN, AST/ALT ≤ 3xULN Note:Patients with documented history of Gilbert's Syndrome and in whom totalbilirubin elevations are accompanied by elevated indirect bilirubin areeligible)

  • Adequate renal function: creatinine clearance (CrCl) of ≥ 45 mL/min The above is a summary, other inclusion criteria details may apply.

Exclusion

  1. Key Exclusion Criteria:
  • Diagnosis of CLL, Burkitt lymphoma, or Richter's transformation

  • Active CNS involvement by B-NHL

  • Leukemic presentation of B-NHL

  • History or presence of clinically relevant CNS pathology such as epilepsy,seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson'sdisease, cerebellar disease, organic brain syndrome, or psychosis

  • Prior therapy with T-cell engager (TCE) within 8 weeks, CAR T- cell therapy orautologous Hematopoietic Stem Cell Transplantation (HSCT) within 12 weeks, orprior allogeneic HSCT within 24 weeks of first dose of AZD0486

  • Requires chronic immunosuppressive therapy

  • Unresolved non hematological AEs ≥ Grade 2 from prior therapies; history of ≥Grade 3 CRS or neurotoxicity from prior CAR-T or TCE therapy

  • History of major cardiac abnormalities.

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

The above is a summary, other exclusion criteria details may apply.

Study Design

Total Participants: 240
Treatment Group(s): 1
Primary Treatment: AZD0486
Phase: 2
Study Start date:
November 27, 2024
Estimated Completion Date:
June 14, 2029

Study Description

This is a modular, Phase II, multicenter, single-arm, open-label study to evaluate the efficacy and safety of AZD0486 monotherapy administered as an intravenous (IV) infusion in participants with relapsed or refractory B-NHL. The purpose of this study is to determine the efficacy and safety of AZD0486 administered at the RP2D in adults 18 to 80 years of age with relapsed or refractory B-NHL.

Connect with a study center

  • Research Site

    Heidelberg, 3084
    Australia

    Active - Recruiting

  • Research Site

    Kogarah, NSW 2217
    Australia

    Site Not Available

  • Research Site

    Macquarie University, 2109
    Australia

    Active - Recruiting

  • Research Site

    Nedlands, 6009
    Australia

    Active - Recruiting

  • Research Site

    Porto Alegre, 90035903
    Brazil

    Site Not Available

  • Research Site

    Sao Paulo, 05652-900
    Brazil

    Site Not Available

  • Research Site

    Barrie, Ontario L4M 6M2
    Canada

    Site Not Available

  • Research Site

    Brampton, Ontario L6R 3J7
    Canada

    Active - Recruiting

  • Research Site

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • Research Site

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Research Site

    Chengdu, 610072
    China

    Site Not Available

  • Research Site

    Guangzhou, 510060
    China

    Site Not Available

  • Research Site

    Nanchang, 330029
    China

    Site Not Available

  • Research Site

    Nanjing, 210029
    China

    Site Not Available

  • Research Site

    Nantong, 226001
    China

    Site Not Available

  • Research Site

    Shandong,
    China

    Site Not Available

  • Research Site

    Shanghai, 200032
    China

    Site Not Available

  • Research Site

    Tianjin, 300020
    China

    Site Not Available

  • Research Site

    Zhengzhou, 450008
    China

    Site Not Available

  • Research Site

    Aalborg, 9100
    Denmark

    Site Not Available

  • Research Site

    Copenhagen, 2100
    Denmark

    Site Not Available

  • Research Site

    Vejle, 7100
    Denmark

    Site Not Available

  • Research Site

    Montpellier, 34295
    France

    Site Not Available

  • Research Site

    Paris, 75010
    France

    Site Not Available

  • Research Site

    Pierre Bénite, 69495
    France

    Site Not Available

  • Research Site

    Rouen Cedex 1, 76038
    France

    Site Not Available

  • Research Site

    Berlin, 10967
    Germany

    Site Not Available

  • Research Site

    Chemnitz, 9116
    Germany

    Site Not Available

  • Research Site

    Essen, 45147
    Germany

    Site Not Available

  • Research Site

    Jena, 07747
    Germany

    Site Not Available

  • Research Site

    Wuerzburg, 97080
    Germany

    Site Not Available

  • Research Site

    Hong Kong, 999077
    Hong Kong

    Site Not Available

  • Research Site

    Shatin, 00000
    Hong Kong

    Site Not Available

  • Research Site

    Alessandria, 15121
    Italy

    Site Not Available

  • Research Site

    Bologna, 40138
    Italy

    Site Not Available

  • Research Site

    Busto Arsizio, 21052
    Italy

    Site Not Available

  • Research Site

    Milan, 20141
    Italy

    Site Not Available

  • Research Site

    Milano, 20132
    Italy

    Site Not Available

  • Research Site

    Roma, 161
    Italy

    Site Not Available

  • Research Site

    Chiba-shi, 260-8717
    Japan

    Active - Recruiting

  • Research Site

    Kashiwa, 277-8577
    Japan

    Site Not Available

  • Research Site

    Koto-ku, 135-8550
    Japan

    Active - Recruiting

  • Research Site

    Kumamoto-shi, 860-0008
    Japan

    Active - Recruiting

  • Research Site

    Niigata-shi, 951-8520
    Japan

    Active - Recruiting

  • Research Site

    Okayama-shi, 700-8558
    Japan

    Active - Recruiting

  • Research Site

    Osaka-shi, 541-8567
    Japan

    Active - Recruiting

  • Research Site

    Yokohama-shi, 241-8515
    Japan

    Active - Recruiting

  • Research Site

    Seoul, 3722
    Korea, Republic of

    Site Not Available

  • Research Site

    Barcelona, 8035
    Spain

    Site Not Available

  • Research Site

    Madrid, 28040
    Spain

    Site Not Available

  • Research Site

    Pozuelo de Alarcon, 28223
    Spain

    Site Not Available

  • Research Site

    Goteborg, 41345
    Sweden

    Site Not Available

  • Research Site

    Stockholm, 17176
    Sweden

    Site Not Available

  • Research Site

    Kaohsiung, 80756
    Taiwan

    Site Not Available

  • Research Site

    Kaohsiung City, 833401
    Taiwan

    Active - Recruiting

  • Research Site

    Taichung, 404
    Taiwan

    Site Not Available

  • Research Site

    Tainan City, 70403
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei City, 106
    Taiwan

    Active - Recruiting

  • Research Site

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • Research Site

    Norwich, NR4 7UY
    United Kingdom

    Site Not Available

  • Research Site

    Nottingham, NG5 1PB
    United Kingdom

    Site Not Available

  • Research Site

    Duarte, California 91010
    United States

    Site Not Available

  • Research Site

    Tampa, Florida 33612
    United States

    Site Not Available

  • Research Site

    Des Moines, Iowa 50314
    United States

    Site Not Available

  • Research Site

    Overland Park, Kansas 66204
    United States

    Site Not Available

  • Research Site

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Research Site

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Research Site

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Research Site

    New York, New York 10016
    United States

    Site Not Available

  • Research Site

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Research Site

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Research Site

    Portland, Oregon 97239
    United States

    Site Not Available

  • Research Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Research Site

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Research Site

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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