NCT07109219 · AstraZeneca
Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic Leukemia
(ALLight)
What this study is about
The study is intended to assess the safety, tolerability, how the drug moves through the body, how the drug affects the body, and effectiveness of AZD4512 in patients with relapsed/refractory B-Cell acute lymphoblastic leukemia (r/r B-ALL).
View original scientific description
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).
Interventions
COMBINATION_PRODUCT
AZD4512 monotherapy
Patients will receive AZD4512 as monotherapy via intravenous infusion. AZD4512 is an antibody-drug conjugate targeting CD22
Primary outcome measures
Module 1 (Dose Escalation): Number of participants with dose-limiting toxicities (DLTs).
Time frame: From first dose up to 21 days (DLT period).
DLTs are dose-limiting toxicities as defined in the study protocol.
Module 1 (Dose Escalation): Frequency, duration and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs)
Time frame: From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
Assessed by the CTCAE criteria version 5.0
Module 1 (Dose Escalation): Frequency of dose interruptions, modifications, delays, and discontinuations due to AEs
Time frame: From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
Module 1 (Dose Escalation): Number of participants with clinically significant changes in laboratory values, ECGs, performance status, and vital signs
Time frame: From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
Module 2 (Dose Optimization): Overall response rate (ORR) in participants with R/R Ph(-) B-ALL
Time frame: From date of first dose of AZD4512 up until end of study, up to 38 months
To evaluate the efficacy based on NCCN response criteria, measured by ORR (CR/CRh)
Module 2 (Dose Optimization): Frequency, duration and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs)
Time frame: From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
Assessed by the CTCAE criteria version 5.0
Module 2 (Dose Optimization): Frequency of dose interruptions, modifications, delays, and discontinuations due to AEs
Time frame: From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
Module 2 (Dose Optimization): Number of participants with clinically significant changes in laboratory values, ECGs, performance status, and vital signs
Time frame: From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 16 years old in Module 1
- 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 (BM blasts \>5%) 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 wit
Where
- Duarte, California
- Jacksonville, Florida
- Chicago, Illinois
- Iowa City, Iowa
- Franklin, Tennessee
- Houston, Texas
Collaborators
Fortrea
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations