RecruitingPhase 1Phase 2NCT06137118

AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

A Phase 1/2 Study to Evaluate the Safety and Efficacy of AZD0486 in Adolescent and Adult Participants With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukaemia

Sponsor

AstraZeneca

Enrollment

163 participants

Start Date

Dec 29, 2023

Study Type

INTERVENTIONAL

Conditions

B-cell Acute Lymphoblastic Leukemia (B-ALL)

Summary

This is a Phase 1/2, global multicentre, open-label, single-arm, dose escalation and dose optimisation study of AZD0486 to evaluate the safety, tolerability, and efficacy of AZD0486 monotherapy in participants with R/R B ALL who have received ≥ 2 prior lines of therapies. The study will consist of 3 parts. Part A monotherapy dose escalation. Part B dose optimisation. Part C Dose expansion at the recommended phase 2 dose (RP2D)

Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called AZD0486 for people with B-cell acute lymphoblastic leukemia (B-ALL), a type of blood cancer where the body makes too many immature white blood cells. The drug is a bispecific antibody that targets a protein called CD19 found on cancer cells. **You may be eligible if...** - You are 12 years old or older - You have B-cell ALL with CD19 expression confirmed by a lab test - Your leukemia has come back or stopped responding after at least 2 prior treatments (or 1 treatment if no standard options remain) - Your leukemia cells are present in the bone marrow at 5% or more - Philadelphia chromosome-positive patients may be eligible if they cannot tolerate or have stopped responding to TKI therapy **You may NOT be eligible if...** - Your overall health status is too poor (performance score above 2 for older teens/adults) - You do not meet organ function requirements - You have not had prior treatment failures as described above Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAZD0486

Investigational Product administered via intravenous infusion.

Locations(80)

Research Site

Birmingham, Alabama, United States

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Duarte, California, United States

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Los Angeles, California, United States

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Palo Alto, California, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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New York, New York, United States

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Houston, Texas, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Milwaukee, Wisconsin, United States

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Melbourne, Australia

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Porto Alegre, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Changsha, China

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Chengdu, China

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Guangzhou, China

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Guangzhou, China

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Hangzhou, China

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Nanjing, China

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Nanjing, China

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Suzhou, China

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Tianjin, China

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Zhengzhou, China

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Caen, France

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Marseille, France

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Nantes, France

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Paris, France

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Pierre-Bénite, France

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Toulouse, France

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Cologne, Germany

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Düsseldorf, Germany

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Essen, Germany

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Frankfurt, Germany

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Freiburg im Breisgau, Germany

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Halle, Germany

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Hamburg, Germany

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Kiel, Germany

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München, Germany

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Münster, Germany

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Würzburg, Germany

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Bergamo, Italy

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Bologna, Italy

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Monza, Italy

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Naples, Italy

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Roma, Italy

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Bunkyō City, Japan

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Chiba, Japan

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Chūōku, Japan

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Fukuoka, Japan

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Kashiwa, Japan

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Kyoto, Japan

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Okayama, Japan

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Osaka, Japan

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Sapporo, Japan

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Toyohashi, Japan

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Yamagata, Japan

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Barcelona, Spain

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Barcelona, Spain

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Madrid, Spain

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Madrid, Spain

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Salamanca, Spain

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Valencia, Spain

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Taoyuan, Taiwan

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London, United Kingdom

Research Site

Manchester, United Kingdom

Research Site

Surrey, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06137118

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