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NCT06542250PHASE1, PHASE2Recruiting

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.

AstraZeneca

Start Date

9/18/2024

Completion Date

12/18/2029

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

Age Range: 18 years to No maximum

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 of therapy; * ECOG performance status of ≤ 2 (\< 2 in EU countries). The above is a summary, other inclusion criteria details may apply. 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 cell therapy 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.

Interventions

DRUG

AZD5492

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Conditions

B-cell Malignancies

Locations

Research Site

La Jolla, California 92093

United States

Research Site

Boston, Massachusetts 02215

United States

Research Site

Rochester, Minnesota 55905

United States

Research Site

Hackensack, New Jersey 07601

United States

Research Site

New York, New York 10021

United States

Research Site

New York, New York 10029

United States

Research Site

Charlotte, North Carolina 28203

United States

Research Site

Winston-Salem, North Carolina 27157

United States

Research Site

Houston, Texas 77030

United States

Research Site

Seattle, Washington 98109

United States

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Melbourne, 3000

Australia

Research Site

Nedlands, 6009

Australia

Research Site

Calgary, Alberta T2N 5G2

Canada

Research Site

Toronto, Ontario M5G 2M9

Canada

Research Site

Montreal, Quebec H3T 1R2

Canada

Research Site

Hangzhou, 310003

China

Research Site

Shanghai, 200025

China

Research Site

København Ø, 2100

Denmark

Research Site

Pessac, 33604

France

Research Site

Villejuif, 94805

France

Research Site

Göttingen, DE-37099

Germany

Research Site

München, 81675

Germany

Research Site

Ulm, 89081

Germany

Research Site

Würzburg, 97080

Germany

Research Site

Bologna, 40138

Italy

Research Site

Milan, 20133

Italy

Research Site

Chūōku, 104-0045

Japan

Research Site

Kashiwa, 277-8577

Japan

Research Site

Barcelona, 08035

Spain

Research Site

L'Hospitalet de Llobregat, 08908

Spain

Research Site

Madrid, 28040

Spain