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Treatment of B-cell Acute Lymphoblastic Leukemia with AZD0486

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

PHASE1; PHASE2 · AstraZeneca · NCT06137118

This study is testing a new drug called AZD0486 to see if it can help people with relapsed or hard-to-treat B-cell Acute Lymphoblastic Leukemia after they have already tried other treatments.

Quick facts

PhasePHASE1; PHASE2
Study typeInterventional
Enrollment163 (estimated)
Ages12 Years and up
SexAll
SponsorAstraZeneca (industry)
Drugs / interventionsCAR-T, CAR T
Locations80 sites (Birmingham, Alabama and 79 other locations)
Trial IDNCT06137118 on ClinicalTrials.gov

What this trial studies

This clinical trial is a Phase 1/2, global multicenter, open-label study evaluating the safety, tolerability, and efficacy of AZD0486 as a monotherapy for patients with relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) who have undergone at least two prior lines of therapy. The study consists of three parts: dose escalation, dose optimization, and dose expansion at the recommended phase 2 dose. Participants will be monitored for pharmacokinetics, pharmacodynamics, and clinical activity of the treatment.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 12 years and older with relapsed or refractory B-ALL who have received at least two prior therapies.

Not a fit: Patients with active central nervous system involvement by B-ALL or isolated extramedullary disease relapse may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-ALL.

How similar studies have performed: Other studies have shown promise in targeting B-cell malignancies, but this specific approach with AZD0486 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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

The above is a summary, other inclusion criteria details may apply.

Exclusion Criteria:

* Active CNS involvement by B-ALL, defined by presence of ALL blasts in CSF (CNS2 and CNS3 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.

The above is a summary, other exclusion criteria details may apply.

Where this trial is running

Birmingham, Alabama and 79 other locations

+30 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: B-cell Acute Lymphoblastic Leukemia, B-cell acute lymphoblastic leukemia, Leukemia, B-lymphocytes, AZD0486

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.