A Modular Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With Relapsed or Refractory B-Cell Malignancies (TITANium)
AstraZeneca
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
- Age range
- 18+ years
- Sex
- All
- 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 includi…
Interventions
- DrugAZD5492
CD8/TCR based T-cell engaging antibody targeting CD20, which is administered subcutaneously
Locations (30)
- Research SiteLa Jolla, California
- Research SiteBoston, Massachusetts
- Research SiteRochester, Minnesota
- Research SiteHackensack, New Jersey
- Research SiteNew York, New York
- Research SiteNew York, New York