AZD4512 alone or with other cancer drugs for relapsed/refractory CD22-positive B‑cell ALL

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 is an open-label, Phase 1/2 multi-center study that enrolls adolescents and adults with relapsed/refractory CD22-positive B‑cell ALL. The trial has two modules: Module 1 uses dose escalation to find a safe dose and Module 2 optimizes dosing. AZD4512 is given as monotherapy and patients may have had prior CD22-targeted therapy. Key outcomes include safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary anti-leukemia activity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. Age:

  * 16 years old in Module 1 (US only: ≥18year)
  * 12 years old in Module 2

    2\. Diagnosis: Known Diagnosis of CD22-positive B-ALL based on criteria established by WHO (Alaggio et al. 2022).
* All Participants must have relapsed or refractory B-ALL ('relapsed' defined as bone marrow blasts \> 5% or reappearance of blasts in PB)
* Module 1 (DE): R/R B-ALL \[Ph(-) and Ph(+)\]
* Backfill of Module 1 and Module 2 (DO): R/R B-ALL \[Ph(-)\] with demonstration of CD22 expression by local assessment in screening.

  3\. Performance status (ECOG ≤ 2; KPS ≥ 50; LPS ≥ 50)

  4\. Peripheral lymphoblast count \< 10,000/µL (may receive cytoreduction prior to C1D1 per protocol-specified criteria)

  5\. Prior therapies:
* Module 1 (DE): At least 2 prior therapies with refractoriness or relapse, or 1 prior therapy with refractoriness or relapse and no standard options available. For Ph+ B-ALL: intolerant to or have contraindications to TKI therapy or R/R disease despite treatment with at least 2 prior TKIs or at least one 3rd generation TKI
* Backfill of Module 1 (backfills) and Module 2 (DO): at least one prior line of therapy (SOC or clinical trial) to which the participant has been either refractory or has subsequently relapsed.
* Participants who have received prior CD22 targeted therapies and were not refractory to these therapies are eligible

  6\. Prior DLI \>4 weeks, prior cell therapy or autoHSCT \>8 weeks, alloHSCT \>12 weeks

Exclusion Criteria:

1. Burkitt lymphoma and leukemia
2. Isolated extramedullary disease; Active testicular or CNS (\> CNS1) involvement
3. Unresolved non-heme toxicities Grade ≥ 2 (except alopecia, stable Grade ≤ 2 neuropathy, vitiligo, endocrine disorders controlled with therapy)
4. History of drug-induced non-infectious ILD/pneumonitis requiring oral or IV steroids or supplemental oxygen or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
5. Prior/concomitant therapy

   * Cytotoxic treatment within 14 days (except ALL maintenance medications or cytoreduction)
   * Biologic (immuno-oncology) treatment within 28 days or 5 half-lives (whichever is shorter)
   * Non-CNS radiation within 2 weeks \& CNS radiation within 4 weeks
   * Medications known to prolong QTc and/or associated with Torsades de Pointes within 5 half-lives
   * Strong inhibitors of CYP 3A4 within 14 days or 5 half-lives (whichever is longer)
   * Investigational agents or study interventions in the last 30 days or 5 half-lives prior to the first dose of AZD4512 whichever is longer.

If the investigational product is an agent to treat B-ALL and meets the modality criteria, then a specific washout period must be adhered to instead.

Where it's running

• Research Site
  Duarte, California, United States Recruiting
• Research Site
  Chicago, Illinois, United States Recruiting
• Research Site
  Iowa City, Iowa, United States Recruiting
• Research Site
  Franklin, Tennessee, United States Recruiting
• Research Site
  Houston, Texas, United States Recruiting
• Research Site
  Melbourne, Australia Recruiting

Study contacts

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

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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.