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.

NCT06542250 · tracked via the Priya Life Science China tracker

Sponsor

AstraZeneca

Phase

Phase 1/2

Started

2024-09-18

Last updated

2026-09-30

Condition(s) studied

B-cell Malignancies

Investigational drug(s) / intervention(s)

AZD5492 →

AZD5492: CD8/TCR based T-cell engaging antibody targeting CD20, which is administered subcutaneously

Study summary

This is a Phase I/II study designed to evaluate if experimental T cell engaging antibody targeting CD20 AZD5492 is safe, tolerable and efficacious in participants with Relapsed or Refractory B-Cell Malignancies.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * ≥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). The above is a summary, other inclusion criteria details may apply. Exclusion Criteria: * 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 The above is a summary, other exclusion criteria details may apply.

Primary outcome measure(s)

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.

Trial sites (31)

Facility	City	Region	Status
Research Site	La Jolla	California	Recruiting
Research Site	Boston	Massachusetts	Withdrawn
Research Site	Rochester	Minnesota	Recruiting
Research Site	Hackensack	New Jersey	Recruiting
Research Site	New York	New York	Recruiting
Research Site	New York	New York	Recruiting
Research Site	Charlotte	North Carolina	Recruiting
Research Site	Winston-Salem	North Carolina	Recruiting
Research Site	Houston	Texas	Recruiting
Research Site	Seattle	Washington	Recruiting
Research Site	Melbourne	Australia	Recruiting
Research Site	Nedlands	Australia	Recruiting
Research Site	Calgary	Alberta	Recruiting
Research Site	Toronto	Ontario	Recruiting
Research Site	Montreal	Quebec	Recruiting
Research Site	Hangzhou	China	Recruiting
Research Site	Shanghai	China	Recruiting
Research Site	København Ø	Denmark	Recruiting
Research Site	Pessac	France	Recruiting
Research Site	Villejuif	France	Recruiting
Research Site	Göttingen	Germany	Recruiting
Research Site	München	Germany	Recruiting
Research Site	Ulm	Germany	Recruiting
Research Site	Würzburg	Germany	Recruiting
Research Site	Bologna	Italy	Recruiting
Research Site	Milan	Italy	Recruiting
Research Site	Chūōku	Japan	Recruiting
Research Site	Kashiwa	Japan	Recruiting
Research Site	Barcelona	Spain	Recruiting
Research Site	L'Hospitalet de Llobregat	Spain	Recruiting
Research Site	Madrid	Spain	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06542250 on ClinicalTrials.gov ↗ ← All trials in China