AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

Last updated: April 30, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

1/2

Condition

Leukemia (Pediatric)

Leukemia

Lymphoma

Treatment

AZD0486

Clinical Study ID

NCT06137118
D7405C00001
2018-002011-10
  • Ages > 12
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Age: 12 years and above (Parts A, B and C).

  • Participants with B-cell Acute Lymphoblastic Leukemia with CD19 expression by locallab with:

  1. Bone marrow infiltration with >/= 5% blasts

  2. Either relapsed or refractory after a minimum of 2 prior therapies or after 1prior line of therapy if no SOC available option.

  3. Philadelphia positive participants are allowed in all parts of the study, ifintolerant 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

Exclusion Criteria:

  • Active CNS involvement by B-ALL, defined by presence of ALL blasts in CSF (CNS2 andCNS3 criteria).

  • 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 4neurotoxicity with CAR-T or TCE therapy.

  • History of other malignancy (with certain exceptions).

  • Unresolved AEs >/= Grade 2, from prior therapies

  • Prior therapy with 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.

Study Design

Total Participants: 163
Treatment Group(s): 1
Primary Treatment: AZD0486
Phase: 1/2
Study Start date:
December 29, 2023
Estimated Completion Date:
June 29, 2027

Study Description

This dose escalation and optimization study is evaluating the safety, tolerability, PK, PD and clinical activity of AZD0486 monotherapy in r/r B-ALL.

Connect with a study center

  • Research Site

    Melbourne, 3000
    Australia

    Active - Recruiting

  • Research Site

    Melbourne 2158177, 3000
    Australia

    Site Not Available

  • Research Site

    Porto Alegre, 90035903
    Brazil

    Active - Recruiting

  • Research Site

    Porto Alegre 3452925, 90035903
    Brazil

    Site Not Available

  • Research Site

    São Paulo, 05652-900
    Brazil

    Active - Recruiting

  • Research Site

    São Paulo 3448439, 01401-002
    Brazil

    Site Not Available

  • Research Site

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Research Site

    Toronto 6167865, Ontario 6093943 M5G 2M9
    Canada

    Site Not Available

  • Research Site

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

  • Research Site

    Montreal 6077243, Quebec 6115047 H3T1C5
    Canada

    Site Not Available

  • Research Site

    Changsha, 410008
    China

    Active - Recruiting

  • Research Site

    Changsha 1815577, 410008
    China

    Site Not Available

  • Research Site

    Chengdu, 610041
    China

    Active - Recruiting

  • Research Site

    Chengdu 1815286, 610041
    China

    Site Not Available

  • Research Site

    Guangzhou, 510060
    China

    Active - Recruiting

  • Research Site

    Guangzhou 1809858, 510280
    China

    Site Not Available

  • Research Site

    Hangzhou, 310003
    China

    Active - Recruiting

  • Research Site

    Hangzhou 1808926, 310003
    China

    Site Not Available

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    Nanjing, 210009
    China

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  • Research Site

    Nanjing 1799962, 210009
    China

    Site Not Available

  • Research Site

    Suzhou, 215006
    China

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  • Research Site

    Suzhou 1886760, 215006
    China

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    Tianjin, 300020
    China

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  • Research Site

    Tianjin 1792947, 300020
    China

    Site Not Available

  • Research Site

    Zhengzhou, 450008
    China

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  • Research Site

    Zhengzhou 1784658, 450008
    China

    Site Not Available

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    Caen, 14033
    France

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  • Research Site

    Caen 3029241, 14033
    France

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    Marseille, 13009
    France

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    Marseille 2995469, 13009
    France

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    Nantes, 44000
    France

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    Nantes 2990969, 44000
    France

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    Paris, 75019
    France

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    Paris 2988507, 75019
    France

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    Pierre Bénite, 69495
    France

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  • Research Site

    Pierre-Bénite, 69495
    France

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  • Research Site

    Pierre-Bénite 2987314, 69495
    France

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    Toulouse, 31059
    France

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    Toulouse 2972315, 31059
    France

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    Cologne, 50924
    Germany

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    Cologne 2886242, 50924
    Germany

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    Düsseldorf, 40225
    Germany

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    Düsseldorf 2934246, 40225
    Germany

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    Essen, 45147
    Germany

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    Essen 2928810, 45147
    Germany

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    Frankfurt, 60590
    Germany

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  • Research Site

    Frankfurt 2925536, 60590
    Germany

    Site Not Available

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    Frankfurt A. Main, 60590
    Germany

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    Freiburg, 79106
    Germany

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    Freiburg im Breisgau, 79106
    Germany

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  • Research Site

    Freiburg im Breisgau 2925177, 79106
    Germany

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  • Research Site

    Halle, 06120
    Germany

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  • Research Site

    Halle 2911522, 06120
    Germany

    Site Not Available

  • Research Site

    Hamburg, 20246
    Germany

    Active - Recruiting

  • Research Site

    Hamburg 2911298, 20246
    Germany

    Site Not Available

  • Research Site

    Kiel, 24105
    Germany

    Active - Recruiting

  • Research Site

    Koeln, 50937
    Germany

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  • Research Site

    Köln, 50924
    Germany

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    Muenchen, D-81377
    Germany

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    München, D-81337
    Germany

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  • Research Site

    München 2867711, D-81337
    Germany

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  • Research Site

    Münster, 48149
    Germany

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  • Research Site

    Münster 2867543, 48149
    Germany

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    Wuerzburg, 97080
    Germany

    Site Not Available

  • Research Site

    Würzburg, 97080
    Germany

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  • Research Site

    Würzburg 2805615, 97080
    Germany

    Site Not Available

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    Bergamo, 24127
    Italy

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  • Research Site

    Bergamo 3182164, 24127
    Italy

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    Bologna, 40138
    Italy

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  • Research Site

    Bologna 3181928, 40138
    Italy

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  • Research Site

    Monza, 20900
    Italy

    Active - Recruiting

  • Research Site

    Monza 3172629, 20900
    Italy

    Site Not Available

  • Research Site

    Naples, 80123
    Italy

    Active - Recruiting

  • Research Site

    Napoli, 80122
    Italy

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    Napoli 9031661, 80123
    Italy

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    Roma, 00165
    Italy

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    Roma 8957247, 00165
    Italy

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    Bunkyo-ku, 113-8677
    Japan

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    Bunkyō City, 113-8677
    Japan

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    Bunkyō City 11790632, 113-8677
    Japan

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    Chiba, 260-8677
    Japan

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    Chiba 2113015, 260-8677
    Japan

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    Chuo-ku, 104-0045
    Japan

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    Chūōku, 104-0045
    Japan

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    Chūōku 10262791, 104-0045
    Japan

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    Fukuoka, 810-8563
    Japan

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    Fukuoka 1863967, 810-8563
    Japan

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    Kashiwa, 277-8577
    Japan

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    Kashiwa 1859924, 277-8577
    Japan

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    Kyoto, 606-8507
    Japan

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  • Research Site

    Kyoto 1857910, 606-8507
    Japan

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    Kyoto-shi, 606-8507
    Japan

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    Okayama, 701-1192
    Japan

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    Okayama 1854383, 701-1192
    Japan

    Site Not Available

  • Research Site

    Osaka, 545-8586
    Japan

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  • Research Site

    Osaka 1853909, 545-8586
    Japan

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    Osaka-shi, 545-8586
    Japan

    Site Not Available

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    Sapporo, 003-0006
    Japan

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  • Research Site

    Sapporo 2128295, 003-0006
    Japan

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    Toyohashi, 441-8570
    Japan

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    Toyohashi 1849846, 441-8570
    Japan

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    Yamagata, 990-9585
    Japan

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    Yamagata 2110556, 990-9585
    Japan

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    Seoul, 6591
    Korea, Republic of

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    Seoul, 06351
    South Korea

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    Seoul 1835848, 6591
    South Korea

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    Barcelona, 08036
    Spain

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    Barcelona 3128760, 08036
    Spain

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    Madrid, 28025
    Spain

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    Madrid 3117735, 28046
    Spain

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    Salamanca, 37007
    Spain

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  • Research Site

    Salamanca 3111108, 37007
    Spain

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  • Research Site

    Valencia, 46026
    Spain

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  • Research Site

    Valencia 2509954, 46026
    Spain

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  • Research Site

    Kaohsiung City, 833401
    Taiwan

    Active - Recruiting

  • Research Site

    Kaohsiung City 1673820, 833401
    Taiwan

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    Taichung, 40705
    Taiwan

    Active - Recruiting

  • Research Site

    Taichung 1668399, 40705
    Taiwan

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    Tainan, 70403
    Taiwan

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  • Research Site

    Tainan 1668355, 70403
    Taiwan

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    Tainan City, 70403
    Taiwan

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  • Research Site

    Tainan City 1668355, 70403
    Taiwan

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  • Research Site

    Taipei, 10002
    Taiwan

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  • Research Site

    Taipei 1668341, 10002
    Taiwan

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  • Research Site

    Taoyuan, 333
    Taiwan

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  • Research Site

    Taoyuan District 1667905, 333
    Taiwan

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  • Research Site

    London, EC1A 7BE
    United Kingdom

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    London 2643743, EC1A 7BE
    United Kingdom

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  • Research Site

    Manchester, M20 4BX
    United Kingdom

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  • Research Site

    Manchester 2643123, M20 4BX
    United Kingdom

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  • Research Site

    Surrey, SM1 2DL
    United Kingdom

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  • Research Site

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Research Site

    Birmingham 4049979, Alabama 4829764 35233
    United States

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  • Research Site

    Duarte, California 91010
    United States

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  • Research Site

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Research Site

    Palo Alto, California 94304
    United States

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  • Research Site

    Duarte 5344147, California 5332921 91010
    United States

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  • Research Site

    Los Angeles 5368361, California 5332921 90048
    United States

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  • Research Site

    Palo Alto 5380748, California 5332921 94304
    United States

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    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Research Site

    Tampa 4174757, Florida 4155751 33612
    United States

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  • Research Site

    Atlanta, Georgia 30322
    United States

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  • Research Site

    Atlanta 4180439, Georgia 4197000 30322
    United States

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  • Research Site

    Chicago, Illinois 60637
    United States

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  • Research Site

    Chicago 4887398, Illinois 4896861 60637
    United States

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    New York, New York 10016
    United States

    Active - Recruiting

  • Research Site

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Research Site

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Research Site

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • Research Site

    Richmond 4781708, Virginia 6254928 23298
    United States

    Site Not Available

  • Research Site

    Seattle, Washington 98109
    United States

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  • Research Site

    Seattle 5809844, Washington 5815135 98109
    United States

    Site Not Available

  • Research Site

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

  • Research Site

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Site Not Available

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