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.

Launched by ASTRAZENECA · Aug 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AZD5492, which is a special type of antibody designed to help the immune system fight certain blood cancers known as B-cell malignancies. This includes conditions like large B-cell lymphoma and chronic lymphocytic leukemia that have come back or did not respond to previous treatments. The researchers want to find out if this treatment is safe, how well it works, and if patients can tolerate it without serious side effects.

To participate in the trial, you need to be at least 18 years old and have been diagnosed with a specific type of B-cell cancer that has not improved after at least two other treatments. You should also be in good enough health to handle the trial procedures. If you join the trial, you will receive the study treatment and be monitored closely by doctors for any effects it may have. This trial is currently recruiting participants, and anyone interested should talk to their healthcare provider for more information.

Gender

ALL

Eligibility criteria

• 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.