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.

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

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.

Conditions2

Locations9 sites

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