A Study to Evaluate Safety, PK, PD and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With R/R B-Cell Malignancies.

Last updated: March 24, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

B-cell Malignancies

Treatment

AZD5492

Clinical Study ID

NCT06542250
D9960C00001
  • Ages > 18
  • All Genders

Study Summary

This is a Phase I/II study designed to evaluate if experimental T cell engaging antibody targeting CD20 AZD5492 is safe, tolerable and efficacious in participants with Relapsed or Refractory B-Cell Malignancies.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥18 years of age;

  • Histologically documented CD20+ mature B-cell neoplasm

  • Large B-cell lymphoma

  • Follicular lymphoma

  • Mantle cell lymphoma

  • Chronic lymphocytic leukemia

  • Small lymphocytic lymphoma

  • Relapsed, progressive and/or refractory disease following at least 2 prior lines oftherapy;

  • ECOG performance status of ≤ 2 (< 2 in EU countries).

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

Exclusion

Exclusion Criteria:

  • Any neoplasm histology not specified in the IC section;

  • Active CNS involvement in lymphoma;

  • CNS pathology including but not limited to any history of seizure disorder/epilepsy;

  • Prior allogeneic HSCT within 180 days, prior autologous HSCT within 90 days, or celltherapy within 90 days of start of therapy;

  • History of Grade ≥ 3 CRS or Grade ≥ 3 ICANS;

  • Active and uncontrolled infections;

  • Unresolved AEs ≥2 Grade due to prior anticancer therapies, with some exceptions

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

Study Design

Total Participants: 174
Treatment Group(s): 1
Primary Treatment: AZD5492
Phase: 1/2
Study Start date:
September 18, 2024
Estimated Completion Date:
February 14, 2028

Connect with a study center

  • Research Site

    Melbourne, 3000
    Australia

    Active - Recruiting

  • Research Site

    Nedlands, 6009
    Australia

    Active - Recruiting

  • Research Site

    Calgary, Alberta T2N 5G2
    Canada

    Active - Recruiting

  • Research Site

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Research Site

    Montreal, Quebec H3T 1R2
    Canada

    Active - Recruiting

  • Research Site

    Hangzhou, 310003
    China

    Site Not Available

  • Research Site

    Shanghai, 200025
    China

    Active - Recruiting

  • Research Site

    København Ø, 2100
    Denmark

    Active - Recruiting

  • Research Site

    Pessac, 33604
    France

    Active - Recruiting

  • Research Site

    München, 81675
    Germany

    Site Not Available

  • Research Site

    Ulm, 89081
    Germany

    Active - Recruiting

  • Research Site

    Wuerzburg, 97080
    Germany

    Active - Recruiting

  • Research Site

    Bologna, 40138
    Italy

    Active - Recruiting

  • Research Site

    Milano, 20133
    Italy

    Active - Recruiting

  • Research Site

    Chuo-ku, 104-0045
    Japan

    Active - Recruiting

  • Research Site

    Kashiwa, 277-8577
    Japan

    Active - Recruiting

  • Research Site

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Research Site

    L'Hospitalet de Llobregat, 08908
    Spain

    Site Not Available

  • Research Site

    Madrid, 28040
    Spain

    Active - Recruiting

  • Research Site

    La Jolla, California 92093
    United States

    Active - Recruiting

  • Research Site

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Research Site

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Research Site

    New York, New York 10021
    United States

    Site Not Available

  • Research Site

    Charlotte, North Carolina 28203
    United States

    Active - Recruiting

  • Research Site

    Concord, North Carolina 28025
    United States

    Site Not Available

  • Research Site

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Research Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Research Site

    Seattle, Washington 98109
    United States

    Active - Recruiting

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