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.

Description

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

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Study Overview

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Study Details

Study 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.

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)

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
B-cell Malignancies
Intervention / Treatment

-

Contacts and Locations

La Jolla

Research Site, La Jolla, California, United States, 92093

Boston

Research Site, Boston, Massachusetts, United States, 02215

Hackensack

Research Site, Hackensack, New Jersey, United States, 07601

New York

Research Site, New York, New York, United States, 10029

Charlotte

Research Site, Charlotte, North Carolina, United States, 28203

Concord

Research Site, Concord, North Carolina, United States, 28025

Houston

Research Site, Houston, Texas, United States, 77030

Seattle

Research Site, Seattle, Washington, United States, 98109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2028-02-16