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AZD0486 for Acute Lymphoblastic Leukemia

Phase 1 & 2
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with CD19+ B-cell Acute Lymphoblastic Leukemia by local lab with bone marrow infiltration with >/= 5% blasts
Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2 OR Lansky score more or equal to 50%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

Study Summary

This trial will evaluate safety, tolerability, & efficacy of AZD0486 monotherapy in R/R B ALL patients who have had ≥ 2 prior therapies. 3 parts: dose escalation, dose optimisation & dose expansion at the RP2D.

Who is the study for?
This trial is for people aged 16+ (Part A) or 12+ (Parts B and C) with a type of blood cancer called CD19+ B-cell Acute Lymphoblastic Leukemia. They must have had at least two prior treatments, or one if no other options exist. Participants should be relatively active and not have severe brain conditions, unresolved serious side effects from past treatments, recent cell therapies or transplants, or active cancer in the brain.Check my eligibility
What is being tested?
The study tests AZD0486 as a single treatment for relapsed/refractory B-cell Acute Lymphoblastic Leukemia. It has three parts: dose escalation to find safe levels (Part A), dose optimization to refine the amount given (Part B), and expansion at the recommended phase 2 dose to see how well it works on more patients (Part C).See study design
What are the potential side effects?
Possible side effects are not detailed here but may include typical reactions related to immune system activation such as fever, fatigue, infusion-related reactions; organ inflammation; blood disorders; increased risk of infections; and neurological issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My leukemia involves more than 5% of bone marrow cells.
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I can do most activities or my child is mostly active and playful.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Frequency of DLTs
Parts A, B, C: Safety Evaluation of AZD0486
Parts B & C: Overall Response Rate (ORR)
Secondary outcome measures
Part A: Objective Response Rate (ORR)
Parts A, B & C: PK Characterization of AZD0486
Parts A, B, & C: PK characterization of AZD0486
+8 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part C: Dose ExpansionExperimental Treatment1 Intervention
Part C will consist of 1 cohort of participants aged 12-80 years, treated with the optimal dose selected in Part B and receive IV AZD0486 monotherapy.
Group II: Part B: Dose OptimizationExperimental Treatment1 Intervention
Up to 2 cohorts will be evaluated prior declared safe-doses and schedules in order to determine the recommended phase 2 dose (RP2D). Participants will receive AZD0486 IV infusions and randomized in a 1:1 ratio.
Group III: Part A: AZD0486 Dose EscalationExperimental Treatment1 Intervention
Ascending dose level cohorts of AZD0486 in B-ALL participants aged 16-80 years.

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Who is running the clinical trial?

AstraZenecaLead Sponsor
4,293 Previous Clinical Trials
288,620,284 Total Patients Enrolled
~80 spots leftby Jan 2026
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