Back to search results

AZD4512 for Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

This study is testing a drug called AZD4512, alone or with other cancer medicines, for people with B-cell Non-Hodgkin Lymphoma (a type of blood cancer) that has come back or not responded to previous treatments. AZD4512 is a special type of drug that targets CD22, a protein found on cancer cells. The main goals are to understand the safety of AZD4512, including any side effects, and to see how well it works. You might be able to join if you are an adult with B-cell Non-Hodgkin Lymphoma and have had at least two prior treatments. The study plans to enroll about 91 participants.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It is a Phase I/II study, which means it will first look at safety and then at how well the treatment works.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored from the first dose up to 30 days after the last dose of study treatment, or until you start another cancer therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07123454

A Phase I/II Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
AstraZeneca
~91 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:AZD4512

At a glance

Recruiting sites
16 of 23 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of participants with dose-limiting toxicities (DLTs)
Measured over Up to 4 weeks
+3 more outcomes measured

Conditions

B-cell Non-Hodgkin Lymphoma

Explore related trials

B-Cell Non-Hodgkin LymphomaDiffuse Large B-Cell LymphomaFollicular LymphomaHigh Grade B-Cell LymphomaMantle Cell LymphomaPrimary Mediastinal Large B-Cell LymphomaT-Cell/Histiocyte-Rich Large B-Cell LymphomaTransformed Indolent Lymphoma

Where it's being run

23 sites across 14 states
Italy3
New York2
Australia2
China2
Japan2
South Korea2
Taiwan2
United Kingdom2

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Eligible patients must be adults (≥18 years)
Documented histologically confirmed diagnosis of B-cell non-Hodgkin lymphoma (B-NHL) as per World Health Organization (WHO) 2022 classification. In the dose escalation phase, any B-NHL subtype is allowed (excluding some subtypes), while the backfill phase restricts inclusion to defined subtypes: large B-cell lymphomas (as defined as Diffuse large B-cell lymphoma (DLBCL), Grade 3b Follicular lymphoma (FL), high-grade B-cell lymphoma (HGBCL) NOS, DLBCL/HGBCL with MYC and BCL2 rearrangements, primary mediastinal Large B-cell lymphoma, T-cell/histiocyte-rich LBCL, and transformed indolent lymphoma) and mantle cell lymphoma.
Patients must have relapsed or refractory disease after at least two prior lines of systemic therapy and lack additional standard options with established benefit:

Exclusion

Patients are excluded if they have a diagnosis of post-transplant lymphoproliferative disease, Richter's transformation, Burkitt's lymphoma, or chronic lymphocytic leukemia (CLL)/ Small lymphocytic lymphoma (SLL), Waldenstrom Macroglobulinemia/ Lymphoplasmacytic Lymphoma, or if they have active Central nervous system (CNS) involvement from their B-NHL. Exclusion also applies to those who have received Chimeric antigen receptor-T (CAR-T) or T cell engager therapies within 90 days prior to Cycle 1 Day 1 (C1D1), any investigational drug or other systemic anticancer therapies (except low-dose corticosteroids) within 21 days or 5 half-lives, and curative radiation within 14 days (localized palliative radiotherapy is allowed).
Other exclusions include allogeneic Hematopoietic stem cell transplantation (HSCT) within 180 days (unless stable without active (graft-versus-host disease) GVHD for ≥2 months), autologous HSCT within 90 days (unless resolved toxicities), major surgery within 28 days, use of strong CYP3A inhibitors within 14 days or 5 half-lives before the dosing date, use of QTc-prolonging agents within 5 half-lives before the dosing date, or other malignancies within two years. Patients with unresolved ≥ Grade 2 AEs from prior therapy (except specified tolerable conditions), serious uncontrolled medical conditions, active infection within 14 days, or history/suspicion of significant interstitial lung disease/pneumonitis are also excluded.
Females who are pregnant or breastfeeding are not eligible.

What this trial measures

  • Percentage of participants with dose-limiting toxicities (DLTs)Up to 4 weeks

    To identify the maximum tolerated dose (MTD) and/or doses of AZD4512 for subsequent evaluation in participants with R/R B-NHL

  • Frequency, duration, severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs)From the first dose up to and including 30 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy

    To assess the safety and tolerability of AZD4512 in participants with R/R B-NHL

  • Frequency of SAEs/AEs leading to discontinuation of AZD4512From the first dose up to and including 30 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy

    To assess the safety and tolerability of AZD4512 in participants with R/R B-NHL

  • Number of participants with clinically significant alterations in vitals signs and abnormal laboratory parametersFrom the first dose up to and including 30 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy

    To assess the safety and tolerability of AZD4512 in participants with R/R B-NHL