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A Study of AZD5492 for Relapsed or Refractory B-Cell Malignancies

This study is testing a new treatment called AZD5492 for people with B-cell malignancies (cancers of certain white blood cells) that have returned or not responded to at least two previous treatments. AZD5492 is an antibody designed to help your own immune system (T cells) fight the cancer by targeting a protein called CD20 on the cancer cells. Researchers want to see if AZD5492 is safe, how well your body handles it, and if it helps treat the cancer. The study will measure how often serious side effects occur and how many participants experience any treatment-related side effects. You may be able to join if you are 18 or older, have a CD20+ B-cell malignancy, and meet other health criteria. The study plans to enroll 174 participants.

Study design
This is a Phase I/II study, meaning it will first look at safety and then at effectiveness. It plans to enroll 174 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for safety and tolerability up to 90 (+7) days after their last dose of study treatment, or until they 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.

NCT06542250

A Study to Evaluate Safety, PK, PD and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With R/R B-Cell Malignancies.

Recruiting
PHASE1Ages 18+InterventionalTreatment
AstraZeneca
~174 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:AZD5492

At a glance

Recruiting sites
29 of 31 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of dose limiting toxicities (DLTs).
Measured over Module 1 - From the first administration of AZD5492 until the end of cycle 1 (up to 5 weeks).
+2 more outcomes measured

Conditions

B-cell Malignancies

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Where it's being run

31 sites across 19 states
Germany4
Spain3
New York2
North Carolina2
Australia2
China2
France2
Italy2

Who to contact

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

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

≥18 years of age;
Histologically documented CD20+ mature B-cell neoplasm
Large B-cell lymphoma
Follicular lymphoma
Mantle cell lymphoma
Chronic lymphocytic leukemia
Small lymphocytic lymphoma
Relapsed, progressive and/or refractory disease following at least 2 prior lines of therapy;
ECOG performance status of ≤ 2 (\< 2 in EU countries).

Exclusion

Any neoplasm histology not specified in the IC section;
Active CNS involvement in lymphoma;
CNS pathology including but not limited to any history of seizure disorder/epilepsy;
Prior allogeneic HSCT within 180 days, prior autologous HSCT within 90 days, or cell therapy within 90 days of start of therapy;
History of Grade ≥ 3 CRS or Grade ≥ 3 ICANS;
Active and uncontrolled infections;
Unresolved AEs ≥2 Grade due to prior anticancer therapies, with some exceptions

What this trial measures

  • Frequency of dose limiting toxicities (DLTs).Module 1 - From the first administration of AZD5492 until the end of cycle 1 (up to 5 weeks).

    DLTs are dose-limiting toxicities as defined in the study protocol.

  • Safety evaluation of AZD5492: Number of participants with treatment-related adverse events.Module 1 - From the first administration of AZD5492 within the duration of the treatment period, up to and including 90 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy.

    Incidence and severity of AEs, AESIs, and SAEs

  • Tolerability evaluation of AZD5492: Number of participants with treatment-related adverse events.Module 1 - From the first administration of AZD5492 within the duration of the treatment period, up to and including 90 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy.

    SAEs/AEs leading to discontinuation of AZD5492.