Immunotherapy in B-Cell Acute Lymphoblastic Leukemia.
Kara L Davis, Catherine C Yao, Jessica A O Zimmerman...
https://pubmed.ncbi.nlm.nih.gov/41671463Actively Recruiting
Phase 1
Phase 2
Age: 12Years +
All Genders
ID06137118
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
Led by AstraZeneca · Updated on 2026-05-27
236
Participants Needed
80
Research Sites
32 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AZD0486, an investigational drug given alone, in adolescents and adults with relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) who have had at least two prior treatments. This Phase 1/2 open-label study is designed to assess the safety, tolerability, and clinical activity of AZD0486. The trial includes participants aged 12 and older and aims to find the best dose and understand how the drug behaves in the body. The study has three parts: Part A involves increasing doses of AZD0486 to find safe levels; Part B focuses on optimizing the dose with participants randomly assigned to one of two dose schedules; Part C expands treatment to more participants using the recommended dose from Part B. All doses are given via intravenous infusion. Participants will receive AZD0486 monotherapy throughout the trial. Participants will be monitored closely for side effects and response to treatment over up to 42 months. Researchers will measure treatment safety, complete remission rates within three cycles, and drug levels in the body. Additional assessments include survival outcomes, duration of remission, and immune response to the drug. The study includes safety evaluations from consent through the study period, with follow-up for long-term effects and treatment outcomes.
CONDITIONS
Brief Title
AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia
Who Can Participate
Age: 12Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 12 years and above (Parts A, B, and C)
- Diagnosis of B-cell Acute Lymphoblastic Leukemia with CD19 expression confirmed locally
- Bone marrow infiltration with 5% or more blasts
- Relapsed or refractory after at least 2 prior therapies, or after 1 prior therapy if no standard options available
- Philadelphia positive participants allowed if intolerant or refractory to tyrosine kinase inhibitors
- ECOG performance status 0 to 2 for participants older than 16 years
- Lansky score 50% or higher for participants 16 years or younger
You will not qualify if you...
- Active CNS involvement by B-ALL with leukemia blasts in cerebrospinal fluid (CNS2 and CNS3 criteria)
- Isolated extramedullary disease relapse
- Testicular leukemia
- History or presence of significant CNS disorders such as epilepsy, seizure, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, or prior Grade 4 neurotoxicity from CAR-T or TCE therapy
- History of other malignancies except certain exceptions
- Unresolved adverse events grade 2 or higher from prior therapies
- Prior T-cell engager therapy within 4 weeks
- Prior CAR T-cell therapy or autologous hematopoietic stem cell transplant within 8 weeks
- Prior allogeneic stem cell transplant within 12 weeks
- Graft-versus-host disease requiring immunosuppressive therapy within 3 weeks before AZD0486 treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to three cycles of 28 days each
Participants receive AZD0486 monotherapy via intravenous infusion in sequential dose escalation, dose optimization, and dose expansion cohorts.
Multiple visits for IV infusions and assessments during each 28-day cycle
Follow-up
Duration - Up to 42 months
Participants are monitored for safety, clinical response, and pharmacokinetics after treatment completion, up to 42 months.
Periodic visits as scheduled for safety and efficacy assessments
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
Suspended
15
Research Site
São Paulo, Brazil, 01401-002
Suspended
16
Research Site
São Paulo, Brazil, 05652-900
Suspended
17
Research Site
Toronto, Ontario, Canada, M5G 2M9
Suspended
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, 215004
Actively Recruiting
28
Research Site
Tianjin, China, 300020
Actively Recruiting
29
Research Site
Zhengzhou, China, 450008
Actively Recruiting
30
Research Site
Caen, France, 14033
Suspended
31
Research Site
Marseille, France, 13009
Suspended
32
Research Site
Nantes, France, 44000
Suspended
33
Research Site
Paris, France, 75019
Suspended
34
Research Site
Pierre-Bénite, France, 69495
Suspended
35
Research Site
Toulouse, France, 31059
Suspended
36
Research Site
Cologne, Germany, 50924
Suspended
37
Research Site
Düsseldorf, Germany, 40225
Suspended
38
Research Site
Essen, Germany, 45147
Withdrawn
39
Research Site
Frankfurt, Germany, 60590
Suspended
40
Research Site
Freiburg im Breisgau, Germany, 79106
Suspended
41
Research Site
Halle, Germany, 06120
Suspended
42
Research Site
Hamburg, Germany, 20246
Suspended
43
Research Site
Kiel, Germany, 24105
Suspended
44
Research Site
München, Germany, D-81337
Suspended
45
Research Site
Münster, Germany, 48149
Suspended
46
Research Site
Würzburg, Germany, 97080
Suspended
47
Research Site
Bergamo, Italy, 24127
Suspended
48
Research Site
Bologna, Italy, 40138
Suspended
49
Research Site
Monza, Italy, 20900
Suspended
50
Research Site
Naples, Italy, 80123
Suspended
51
Research Site
Roma, Italy, 00165
Suspended
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
Suspended
68
Research Site
Barcelona, Spain, 8035
Suspended
69
Research Site
Madrid, Spain, 28025
Suspended
70
Research Site
Madrid, Spain, 28046
Suspended
71
Research Site
Salamanca, Spain, 37007
Suspended
72
Research Site
Valencia, Spain, 46026
Active, Not Recruiting
73
Research Site
Kaohsiung City, Taiwan, 833401
Suspended
74
Research Site
Taichung, Taiwan, 40705
Suspended
75
Research Site
Tainan, Taiwan, 70403
Suspended
76
Research Site
Taipei, Taiwan, 10002
Suspended
77
Research Site
Taoyuan, Taiwan, 333
Suspended
78
Research Site
London, United Kingdom, EC1A 7BE
Suspended
79
Research Site
Manchester, United Kingdom, M20 4BX
Suspended
80
Research Site
Surrey, United Kingdom, SM1 2DL
Suspended
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Research Team
A
AstraZeneca Clinical Study Information Center
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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