NCT06542250

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.

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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• B-cell Malignancies

Interventions

Type	Name	Description
DRUG	AZD5492	CD8/TCR based T-cell engaging antibody targeting CD20, which is administered subcutaneously

Timeline

• Start date: 2024-09-18
• Primary completion: 2028-02-14
• Completion: 2028-02-14
• First posted: 2024-08-07
• Last updated: 2026-03-27

Locations

29 sites across 10 countries: United States, Australia, Canada, China, Denmark, France, Germany, Italy, Japan, Spain

Regulatory

• FDA-regulated drug study