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New hope for tough leukemia: experimental drug AZD0486 enters human trials

NCT ID NCT06137118

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This study tests an experimental drug called AZD0486 in adolescents and adults whose B-cell acute lymphoblastic leukemia (B-ALL) has returned or not responded to at least two prior treatments. The trial has three parts: first, finding a safe dose; second, optimizing that dose; and third, testing the best dose in a larger group. The main goals are to check safety and see if the drug can achieve complete remission within three cycles of treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AZD0486 (a drug given by IV infusion)
What this could lead to
If it works, this could offer a new treatment option for people with B-cell acute lymphoblastic leukemia that has come back or not responded to other therapies.
What could go wrong
This is an early-phase trial (Phase 1/2) with only 236 participants, so the drug may not prove effective or safe enough for wider use. Side effects, including serious ones, are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 255 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age: 12 years and above (Parts A, B, C and D). * Participants with B-cell Acute Lymphoblastic Leukemia with CD19 expression by local lab with: 1. Bone marrow infiltration with \>/= 5% blasts 2. Either relapsed or refractory after a minimum of 2 prior therapies or after 1 prior line of therapy if no SOC available option (Parts A, B, C); or relapsed or refractory to ≥1 prior line of therapy (Part D). 3. Philadelphia positive participants are allowed in all parts of the study, if intolerant or refractory to TKIs. * For participants older than 16 years, Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2. For Participants 16 years or younger, Lansky score more or equal to 50%. The above is a summary, other inclusion criteria details may apply. Exclusion Criteria: * Active CNS involvement by B-ALL, defined by presence of ALL blasts in CSF (CNS2 and CNS3 criteria), or signs of CNS involvement. * Isolated extramedullary disease relapse. * Testicular leukemia * History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis; or prior Grade 4 neurotoxicity with CAR-T or TCE therapy. * History of other malignancy (with certain exceptions). * Unresolved AEs \>/= Grade 2, from prior therapies * Prior therapy with ADCs within 3 weeks, TCEs within 4 weeks, CAR T-cell therapy or autologous HSCT within 8 weeks or prior alloSCT within 12 weeks of start of therapy. * GVHD requiring immunosuppressive therapy within 3 weeks prior to AZD0486 treatment. The above is a summary, other exclusion criteria details may apply.

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Conditions

The condition(s) this trial relates to.

B-cell acute lymphoblastic leukemia Burkitt lymphoma leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

B-cell acute lymphoblastic leukemia (B-ALL)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    75 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    WITHDRAWN

    Birmingham, Alabama, 35205, United States

  • Research Site

    RECRUITING

    Duarte, California, 91010, United States

  • Research Site

    RECRUITING

    Los Angeles, California, 90048, United States

  • Research Site

    RECRUITING

    Palo Alto, California, 94304, United States

  • Research Site

    RECRUITING

    Tampa, Florida, 33612, United States

  • Research Site

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Research Site

    RECRUITING

    Chicago, Illinois, 60637, United States

  • Research Site

    RECRUITING

    New York, New York, 10016, United States

  • Research Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Research Site

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Research Site

    WITHDRAWN

    Seattle, Washington, 98109, United States

  • Research Site

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Research Site

    WITHDRAWN

    Melbourne, 3000, Australia

  • Research Site

    SUSPENDED

    Porto Alegre, 90035903, Brazil

  • Research Site

    SUSPENDED

    São Paulo, 01401-002, Brazil

  • Research Site

    SUSPENDED

    São Paulo, 05652-900, Brazil

  • Research Site

    SUSPENDED

    Toronto, Ontario, M5G 2M9, Canada

  • Research Site

    WITHDRAWN

    Montreal, Quebec, H3T1C5, Canada

  • Research Site

    WITHDRAWN

    Montreal, Quebec, H4A 3J1, Canada

  • Research Site

    RECRUITING

    Changsha, 410008, China

  • Research Site

    RECRUITING

    Chengdu, 610041, China

  • Research Site

    RECRUITING

    Guangzhou, 510060, China

  • Research Site

    RECRUITING

    Guangzhou, 510280, China

  • Research Site

    RECRUITING

    Hangzhou, 310003, China

  • Research Site

    RECRUITING

    Nanjing, 210008, China

  • Research Site

    RECRUITING

    Nanjing, 210009, China

  • Research Site

    RECRUITING

    Suzhou, 215004, China

  • Research Site

    RECRUITING

    Tianjin, 300020, China

  • Research Site

    RECRUITING

    Zhengzhou, 450008, China

  • Research Site

    SUSPENDED

    Caen, 14033, France

  • Research Site

    SUSPENDED

    Marseille, 13009, France

  • Research Site

    SUSPENDED

    Nantes, 44000, France

  • Research Site

    SUSPENDED

    Paris, 75019, France

  • Research Site

    SUSPENDED

    Pierre-Bénite, 69495, France

  • Research Site

    SUSPENDED

    Toulouse, 31059, France

  • Research Site

    NOT_YET_RECRUITING

    Berlin, 13353, Germany

  • Research Site

    SUSPENDED

    Cologne, 50924, Germany

  • Research Site

    SUSPENDED

    Düsseldorf, 40225, Germany

  • Research Site

    WITHDRAWN

    Essen, 45147, Germany

  • Research Site

    SUSPENDED

    Frankfurt, 60590, Germany

  • Research Site

    SUSPENDED

    Freiburg im Breisgau, 79106, Germany

  • Research Site

    SUSPENDED

    Halle, 06120, Germany

  • Research Site

    SUSPENDED

    Hamburg, 20246, Germany

  • Research Site

    SUSPENDED

    Kiel, 24105, Germany

  • Research Site

    SUSPENDED

    München, D-81337, Germany

  • Research Site

    SUSPENDED

    Münster, 48149, Germany

  • Research Site

    SUSPENDED

    Würzburg, 97080, Germany

  • Research Site

    SUSPENDED

    Bergamo, 24127, Italy

  • Research Site

    SUSPENDED

    Bologna, 40138, Italy

  • Research Site

    SUSPENDED

    Monza, 20900, Italy

  • Research Site

    SUSPENDED

    Naples, 80123, Italy

  • Research Site

    SUSPENDED

    Roma, 00165, Italy

  • Research Site

    RECRUITING

    Bunkyō City, 113-8677, Japan

  • Research Site

    RECRUITING

    Chiba, 260-8677, Japan

  • Research Site

    RECRUITING

    Chūōku, 104-0045, Japan

  • Research Site

    RECRUITING

    Fukuoka, 810-8563, Japan

  • Research Site

    RECRUITING

    Kashiwa, 277-8577, Japan

  • Research Site

    RECRUITING

    Kyoto, 606-8507, Japan

  • Research Site

    RECRUITING

    Okayama, 701-1192, Japan

  • Research Site

    RECRUITING

    Osaka, 545-8586, Japan

  • Research Site

    RECRUITING

    Sapporo, 003-0006, Japan

  • Research Site

    RECRUITING

    Toyohashi, 441-8570, Japan

  • Research Site

    RECRUITING

    Yamagata, 990-9585, Japan

  • Research Site

    RECRUITING

    Seoul, 03080, South Korea

  • Research Site

    RECRUITING

    Seoul, 03722, South Korea

  • Research Site

    NOT_YET_RECRUITING

    Seoul, 05505, South Korea

  • Research Site

    RECRUITING

    Seoul, 06351, South Korea

  • Research Site

    RECRUITING

    Seoul, 6591, South Korea

  • Research Site

    SUSPENDED

    Barcelona, 08036, Spain

  • Research Site

    SUSPENDED

    Barcelona, 8035, Spain

  • Research Site

    SUSPENDED

    Madrid, 28025, Spain

  • Research Site

    SUSPENDED

    Madrid, 28046, Spain

  • Research Site

    SUSPENDED

    Salamanca, 37007, Spain

  • Research Site

    COMPLETED

    Valencia, 46026, Spain

  • Research Site

    SUSPENDED

    Kaohsiung City, 833401, Taiwan

  • Research Site

    SUSPENDED

    Taichung, 40705, Taiwan

  • Research Site

    SUSPENDED

    Tainan, 70403, Taiwan

  • Research Site

    SUSPENDED

    Taipei, 10002, Taiwan

  • Research Site

    SUSPENDED

    Taoyuan, 333, Taiwan

  • Research Site

    SUSPENDED

    London, EC1A 7BE, United Kingdom

  • Research Site

    SUSPENDED

    Manchester, M20 4BX, United Kingdom

  • Research Site

    SUSPENDED

    Surrey, SM1 2DL, United Kingdom

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