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. - TITANium

Study identifier:D9960C00001

ClinicalTrials.gov identifier:NCT06542250

EudraCT identifier:N/A

CTIS identifier:2024-511099-34-00

Recruiting

Official Title

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)

Medical condition

B-cell Malignancies

Phase

Phase 1/2

Healthy volunteers

No

Study drug

AZD5492

Sex

All

Estimated Enrollment

174

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 18 Sept 2024
Estimated Primary Completion Date: 16 Feb 2028
Estimated Study Completion Date: 16 Feb 2028

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria