Actively Recruiting
AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia
Led by AstraZeneca · Updated on 2026-05-01
163
Participants Needed
80
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12 years and older
- Diagnosis of B-cell Acute Lymphoblastic Leukemia with CD19 expression confirmed by local lab
- Bone marrow infiltration with at least 5% blasts
- Relapsed or refractory disease after at least 2 prior therapies, or after 1 prior therapy if no standard treatment options exist
- Philadelphia chromosome-positive patients allowed if intolerant or refractory to tyrosine kinase inhibitors
- For participants older than 16 years, ECOG Performance Status of 0 to 2
- For participants 16 years or younger, Lansky score of 50% or higher
You will not qualify if you...
- Active central nervous system involvement by B-ALL (presence of blasts in cerebrospinal fluid meeting CNS2 or CNS3 criteria)
- Isolated extramedullary disease relapse
- Testicular leukemia
- History or presence of significant central nervous system diseases such as epilepsy, seizures, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, or prior Grade 4 neurotoxicity with CAR-T or T-cell engager therapy
- History of other malignancies (with some exceptions)
- Unresolved adverse events of Grade 2 or higher from previous therapies
- Prior T-cell engager therapy within 4 weeks, CAR T-cell therapy or autologous stem cell transplant within 8 weeks, or allogeneic stem cell transplant within 12 weeks before starting AZD0486
- Graft-versus-host disease requiring immunosuppressive therapy within 3 weeks before treatment with AZD0486
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 80 locations
1
Research Site
Birmingham, Alabama, United States, 35233
Withdrawn
2
Research Site
Duarte, California, United States, 91010
Actively Recruiting
3
Research Site
Los Angeles, California, United States, 90048
Actively Recruiting
4
Research Site
Palo Alto, California, United States, 94304
Actively Recruiting
5
Research Site
Tampa, Florida, United States, 33612
Actively Recruiting
6
Research Site
Atlanta, Georgia, United States, 30322
Actively Recruiting
7
Research Site
Chicago, Illinois, United States, 60637
Actively Recruiting
8
Research Site
New York, New York, United States, 10016
Actively Recruiting
9
Research Site
Houston, Texas, United States, 77030
Actively Recruiting
10
Research Site
Richmond, Virginia, United States, 23298
Actively Recruiting
11
Research Site
Seattle, Washington, United States, 98109
Withdrawn
12
Research Site
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
13
Research Site
Melbourne, Australia, 3000
Actively Recruiting
14
Research Site
Porto Alegre, Brazil, 90035903
Actively Recruiting
15
Research Site
São Paulo, Brazil, 01401-002
Actively Recruiting
16
Research Site
São Paulo, Brazil, 05652-900
Actively Recruiting
17
Research Site
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
18
Research Site
Montreal, Quebec, Canada, H3T1C5
Withdrawn
19
Research Site
Montreal, Quebec, Canada, H4A 3J1
Withdrawn
20
Research Site
Changsha, China, 410008
Actively Recruiting
21
Research Site
Chengdu, China, 610041
Actively Recruiting
22
Research Site
Guangzhou, China, 510060
Actively Recruiting
23
Research Site
Guangzhou, China, 510280
Actively Recruiting
24
Research Site
Hangzhou, China, 310003
Actively Recruiting
25
Research Site
Nanjing, China, 210008
Actively Recruiting
26
Research Site
Nanjing, China, 210009
Actively Recruiting
27
Research Site
Suzhou, China, 215006
Actively Recruiting
28
Research Site
Tianjin, China, 300020
Actively Recruiting
29
Research Site
Zhengzhou, China, 450008
Actively Recruiting
30
Research Site
Caen, France, 14033
Actively Recruiting
31
Research Site
Marseille, France, 13009
Actively Recruiting
32
Research Site
Nantes, France, 44000
Actively Recruiting
33
Research Site
Paris, France, 75019
Actively Recruiting
34
Research Site
Pierre-Bénite, France, 69495
Actively Recruiting
35
Research Site
Toulouse, France, 31059
Actively Recruiting
36
Research Site
Cologne, Germany, 50924
Actively Recruiting
37
Research Site
Düsseldorf, Germany, 40225
Actively Recruiting
38
Research Site
Essen, Germany, 45147
Withdrawn
39
Research Site
Frankfurt, Germany, 60590
Actively Recruiting
40
Research Site
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
41
Research Site
Halle, Germany, 06120
Actively Recruiting
42
Research Site
Hamburg, Germany, 20246
Actively Recruiting
43
Research Site
Kiel, Germany, 24105
Actively Recruiting
44
Research Site
München, Germany, D-81337
Actively Recruiting
45
Research Site
Münster, Germany, 48149
Actively Recruiting
46
Research Site
Würzburg, Germany, 97080
Actively Recruiting
47
Research Site
Bergamo, Italy, 24127
Actively Recruiting
48
Research Site
Bologna, Italy, 40138
Actively Recruiting
49
Research Site
Monza, Italy, 20900
Actively Recruiting
50
Research Site
Naples, Italy, 80123
Actively Recruiting
51
Research Site
Roma, Italy, 00165
Actively Recruiting
52
Research Site
Bunkyō City, Japan, 113-8677
Actively Recruiting
53
Research Site
Chiba, Japan, 260-8677
Actively Recruiting
54
Research Site
Chūōku, Japan, 104-0045
Actively Recruiting
55
Research Site
Fukuoka, Japan, 810-8563
Actively Recruiting
56
Research Site
Kashiwa, Japan, 277-8577
Actively Recruiting
57
Research Site
Kyoto, Japan, 606-8507
Actively Recruiting
58
Research Site
Okayama, Japan, 701-1192
Actively Recruiting
59
Research Site
Osaka, Japan, 545-8586
Actively Recruiting
60
Research Site
Sapporo, Japan, 003-0006
Actively Recruiting
61
Research Site
Toyohashi, Japan, 441-8570
Actively Recruiting
62
Research Site
Yamagata, Japan, 990-9585
Actively Recruiting
63
Research Site
Seoul, South Korea, 03080
Actively Recruiting
64
Research Site
Seoul, South Korea, 03722
Actively Recruiting
65
Research Site
Seoul, South Korea, 06351
Actively Recruiting
66
Research Site
Seoul, South Korea, 6591
Actively Recruiting
67
Research Site
Barcelona, Spain, 08036
Actively Recruiting
68
Research Site
Barcelona, Spain, 8035
Actively Recruiting
69
Research Site
Madrid, Spain, 28025
Actively Recruiting
70
Research Site
Madrid, Spain, 28046
Actively Recruiting
71
Research Site
Salamanca, Spain, 37007
Actively Recruiting
72
Research Site
Valencia, Spain, 46026
Active, Not Recruiting
73
Research Site
Kaohsiung City, Taiwan, 833401
Actively Recruiting
74
Research Site
Taichung, Taiwan, 40705
Actively Recruiting
75
Research Site
Tainan, Taiwan, 70403
Actively Recruiting
76
Research Site
Taipei, Taiwan, 10002
Actively Recruiting
77
Research Site
Taoyuan, Taiwan, 333
Actively Recruiting
78
Research Site
London, United Kingdom, EC1A 7BE
Actively Recruiting
79
Research Site
Manchester, United Kingdom, M20 4BX
Actively Recruiting
80
Research Site
Surrey, United Kingdom, SM1 2DL
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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