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New antibody drug takes aim at relapsed leukemia

NCT ID NCT07109219

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times

Summary

This study tests a new drug called AZD4512 for people with B-cell acute lymphoblastic leukemia (B-ALL) that has returned or not responded to treatment. The drug is an antibody-drug conjugate that delivers a toxic payload directly to cancer cells. The trial has two parts: first, finding a safe dose, then checking how well it works. About 83 participants will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AZD4512, an antibody-drug conjugate that targets CD22 on cancer cells
What this could lead to
If it works, this could offer a new treatment option for people with B-cell acute lymphoblastic leukemia that has come back or not responded to other therapies.
What could go wrong
This is an early-phase trial with only 83 participants, so it may not show strong enough results or could have unexpected side effects. The drug is still experimental.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 83 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

B-cell acute lymphoblastic leukemia Burkitt lymphoma Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

B-cell acute lymphoblastic leukemia (B-ALL)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Duarte, California, 91010, United States

  • Research Site

    WITHDRAWN

    Jacksonville, Florida, 32224, United States

  • Research Site

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Research Site

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Research Site

    RECRUITING

    Franklin, Tennessee, 37067, United States

  • Research Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Research Site

    RECRUITING

    Melbourne, 3000, Australia

  • Research Site

    NOT_YET_RECRUITING

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Research Site

    RECRUITING

    Toronto, Ontario, M5G 1X6, Canada

  • Research Site

    NOT_YET_RECRUITING

    Guangzhou, 510515, China

  • Research Site

    NOT_YET_RECRUITING

    Tianjin, 301600, China

  • Research Site

    RECRUITING

    Bunkyō City, 113-8677, Japan

  • Research Site

    RECRUITING

    Chūōku, 104-0045, Japan

  • Research Site

    RECRUITING

    Seoul, 03080, South Korea

  • Research Site

    RECRUITING

    Seoul, 06351, South Korea

  • Research Site

    RECRUITING

    Seoul, 06591, South Korea

  • Research Site

    RECRUITING

    Seoul, 3722, South Korea

  • Research Site

    NOT_YET_RECRUITING

    Badalona(Barcelona), 08916, Spain

  • Research Site

    RECRUITING

    Barcelona, 08035, Spain

  • Research Site

    RECRUITING

    Salamanca, 37007, Spain

  • Research Site

    RECRUITING

    Santander, 39008, Spain

  • Research Site

    WITHDRAWN

    Valencia, 46026, Spain

  • Research Site

    RECRUITING

    Taichung, 40705, Taiwan

  • Research Site

    RECRUITING

    Taipei, 106, Taiwan

  • Research Site

    RECRUITING

    Bloomsbury, W1T 7HA, United Kingdom

  • Research Site

    RECRUITING

    Manchester, M20 4BX, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.