AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia
NCT ID: NCT06137118
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
163 participants
INTERVENTIONAL
2023-12-29
2027-06-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A: AZD0486 Dose Escalation
Ascending dose level cohorts of AZD0486 in B-ALL participants aged 12 years and above.
AZD0486
Investigational Product administered via intravenous infusion.
Part B: Dose Optimization
Up to 2 cohorts will be evaluated prior declared safe-doses and schedules in order to determine the recommended phase 2 dose (RP2D). Participants, aged 12 years and above, will receive AZD0486 IV infusions and will be randomized in a 1:1 ratio.
AZD0486
Investigational Product administered via intravenous infusion.
Part C: Dose Expansion
Part C will consist of 1 cohort of participants aged 12 years and above, treated with the optimal dose selected in Part B and receive IV AZD0486 monotherapy.
AZD0486
Investigational Product administered via intravenous infusion.
Interventions
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AZD0486
Investigational Product administered via intravenous infusion.
Eligibility Criteria
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Inclusion Criteria
* 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.
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%.
Exclusion 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 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 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.
12 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Birmingham, Alabama, United States
Research Site
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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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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Napoli, , 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 District, , Taiwan
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London, , United Kingdom
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Manchester, , United Kingdom
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Surrey, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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D7405C00001
Identifier Type: -
Identifier Source: org_study_id
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