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.

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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)

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