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

A Modular Phase I/II, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of AZD4512 Monotherapy or in Combination With Anticancer Agent(s) in Participants With Acute Lymphoblastic Leukemia

Phase1; Phase2 Interventional AstraZeneca · NCT07109219

This trial will test whether AZD4512, given alone, is safe and can help adults and adolescents with relapsed or refractory CD22-positive B‑cell acute lymphoblastic leukemia.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment83 (estimated)
Ages12 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsradiation
Locations26 sites (Duarte, California and 25 other locations)
Trial IDNCT07109219 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥16 years, ≥18 in the US) and adolescents (≥12 years) with relapsed or refractory CD22-positive B‑cell ALL, adequate performance status, and prior therapy history (typically ≥2 prior therapies or 1 if no standard options) are ideal candidates.

Not a fit: Patients without CD22 expression, those with uncontrolled medical problems or very high circulating blast counts above protocol limits, or those who have effective standard treatment options available are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, AZD4512 could offer a new targeted treatment option that reduces leukemia burden in patients with relapsed/refractory CD22-positive B‑cell ALL.

How similar studies have performed: Similar CD22-targeting antibody‑drug conjugates such as inotuzumab ozogamicin have shown responses in relapsed/refractory B‑ALL, so the approach has precedent.

Eligibility criteria

Show full inclusion / exclusion criteria 
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).
* Participants must have relapsed or refractory B-ALL ('relapsed' defined as bone marrow blasts \> 5% or reappearance of blasts in PB)
* Module 1 (DE): Ph(-) B-ALL and Ph(+) B-ALL - R/R
* Backfill of Module 1 and Module 2 (DO): R/R Ph(-) B-ALL

  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\. At least 2 prior therapies with refractoriness or relapse, or 1 prior therapy with refractoriness or relapse and no standard options available. Participants who have received prior CD22 targeted therapies are eligible.
* Ph+ B-ALL (Module 1 DE only): 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

  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 this trial is running

Duarte, California and 25 other locations

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 → Find more trials like this →
Conditions B-cell Acute Lymphoblastic LeukemiaAcute lymphoblastic leukemiaDose escalationDose optimizationCluster of differentiation 22Antibody-drug conjugate
Last reviewed 2026-06-13 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.