At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- AZD4512 monotherapy (combination product)
- How long the study runs
- Study runs about 32 months (dates as stated)
- About the drug or intervention
- AZD4512 monotherapy — combination product: Patients will receive AZD4512 as monotherapy via intravenous infusion.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by AstraZeneca, is testing a drug called AZD4512 on its own or with other anti-cancer medicines in people with B-cell acute lymphoblastic leukaemia (B-ALL) that has come back (relapsed) or has not responded to treatment (refractory). B-ALL is a cancer of a type of white blood cell called B cells, and in this trial the cancer cells must carry a marker called CD22.
Who can take part
- Age 16 or over in Module 1 (in the US, 18 or over), or age 12 or over in Module 2
- A diagnosis of CD22-positive B-cell acute lymphoblastic leukaemia, based on World Health Organization criteria
- Leukaemia that has relapsed (come back) or is refractory (did not respond to treatment)
- At least 2 previous treatments that failed, or 1 previous treatment that failed with no standard options left; people who have had CD22-targeted treatments before can still take part
- For a subtype called Ph+ B-ALL (Module 1 only): unable to tolerate drugs called TKIs, or the disease came back despite at least 2 TKIs or one 3rd-generation TKI
- Well enough for the study (measured by performance scores) and not too many leukaemia cells in the blood (some reduction treatment beforehand may be allowed)
- Enough time must have passed since previous cell therapy, donor cell infusion, or stem cell transplants (4, 8 or 12 weeks depending on the type)
Who may not be able to
- Having Burkitt lymphoma or leukaemia
- Cancer only outside the bone marrow, or active disease in the brain, spinal cord or testicles
- Ongoing side effects from earlier treatment that are Grade 2 or worse (with some exceptions, such as hair loss)
- A history of drug-induced lung inflammation (called ILD or pneumumonitis) that needed steroid tablets or drip, oxygen, or where it cannot be ruled out on scans
- Recent anti-cancer treatment: chemotherapy within 14 days, immunotherapy within 28 days or 5 half-lives, radiotherapy within 2-4 weeks, or other experimental drugs within 30 days or 5 half-lives
- Recent use of certain medicines, including drugs that affect heart rhythm (QTc) or strong blockers of a liver enzyme called CYP3A4
What taking part involves
- • Taking the study drug AZD4512 on its own
- • Taking AZD4512 together with other anti-cancer medicines
- • The study has parts called Module 1 and Module 2 covering slightly different types of B-ALL
Time commitment: Not stated — ask the trial team about how long the study lasts, how often visits happen, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 12 Years and over
- Who
- All
- Number of participants
- 83
- Started
- 2025-11-12
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for b-cell acute lymphoblastic leukemia (b-all)
- • Phase1/Phase2 - 83 participants
- • The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD4512 in patients with relapsed/refractory B-Cell acute lymphoblastic leukemia (r/r B-ALL)
Who can take part?
- • Ages 12 Years and over
- • Diagnosed with b-cell acute lymphoblastic leukemia (b-all)
Where?
- • Bloomsbury - Research Site
- • Manchester - Research Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD4512 in patients with relapsed/refractory B-Cell acute lymphoblastic leukemia (r/r B-ALL).
More detail
In this Phase I/II, open-label multi-center study AZD4512 will be administered to adult/young adult patients (Module 1: \>=16 years; Module 2: \>=12 years) with relapsed/refractory B-Cell acute lymphoblastic leukemia (B-ALL). This study will have 2 parts: Module 1 - Dose Escalation and Module 2 - Dose Optimization.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 12 Years and over
- Who can join: All genders
- How fit you need to be: ECOG 2 or better
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ refract
What the study is looking for
- ✓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...
Who cannot take part
- ✗Burkitt lymphoma and leukemia
- ✗Isolated extramedullary disease; Active testicular or CNS (\> CNS1) involvement
- ✗Unresolved non-heme toxicities Grade ≥ 2 (except alopecia, stable Grade ≤ 2 neuropathy, vitiligo, endocrine...
- ✗History of drug-induced non-infectious ILD/pneumonitis requiring oral or IV steroids or supplemental oxygen or where...
- ✗Prior/concomitant therapy
See the full criteria
Where Is This Study? (2 UK sites)
Research Site
Bloomsbury W1T 7HA, United Kingdom
Research Site
Manchester M20 4BX, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
