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.

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06542250

Patient View

This Phase I/II trial assesses the safety, tolerability, and efficacy of AZD5492, a CD8/TCR-based T-cell engaging antibody, in adults with CD20+ B-cell neoplasms, including various lymphomas and chronic lymphocytic leukemia. Eligible participants must have relapsed or refractory disease after at least two prior therapies and an ECOG status of ≤ 2. AZD5492 is administered subcutaneously.

Patient Parameters

Program Overview

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 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.

The above is a summary, other inclusion criteria details may apply.

Exclusion Criteria

  • Active CNS involvement in lymphoma or CNS pathology;
  • Diagnosis of post-transplant lymphoproliferative disease, Richter's transformation, Burkitt's lymphoma, or Burkitt-like lymphoma;
  • 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.

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