Treatment of B-cell Acute Lymphoblastic Leukemia with AZD0486

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age: 12 years and above (Parts A, B, C and D).
* 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 (Parts A, B, C); or relapsed or refractory to ≥1 prior line of therapy (Part D).
  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), or signs of CNS involvement.
* 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 ADCs within 3 weeks, 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 it's running

• Research Site
  Duarte, California, United States Recruiting
• Research Site
  Los Angeles, California, United States Recruiting
• Research Site
  Palo Alto, California, United States Recruiting
• Research Site
  Tampa, Florida, United States Recruiting
• Research Site
  Atlanta, Georgia, United States Recruiting
• Research Site
  Chicago, Illinois, United States Recruiting

+33 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.