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
No
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.
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.
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