RECRUITING

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.

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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)

Quick Facts

Study Start:2024-09-18
Study Completion:2028-02-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06542250

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥18 years of age;
  2. * Histologically documented CD20+ mature B-cell neoplasm
  3. * Large B-cell lymphoma
  4. * Follicular lymphoma
  5. * Mantle cell lymphoma
  6. * Chronic lymphocytic leukemia
  7. * Small lymphocytic lymphoma
  8. * Relapsed, progressive and/or refractory disease following at least 2 prior lines of therapy;
  9. * ECOG performance status of ≤ 2.
  1. * Active CNS involvement in lymphoma or CNS pathology;
  2. * Diagnosis of post-transplant lymphoproliferative disease, Richter's transformation, Burkitt's lymphoma, or Burkitt-like lymphoma;
  3. * Prior allogeneic HSCT within 180 days, prior autologous HSCT within 90 days, or cell therapy within 90 days of start of therapy;
  4. * History of Grade ≥ 3 CRS or Grade ≥ 3 ICANS;
  5. * Active and uncontrolled infections;
  6. * Unresolved AEs ≥2 Grade due to prior anticancer therapies, with some exceptions

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
La Jolla, California, 92093
United States
Research Site
Boston, Massachusetts, 02215
United States
Research Site
Hackensack, New Jersey, 07601
United States
Research Site
New York, New York, 10029
United States
Research Site
Charlotte, North Carolina, 28203
United States
Research Site
Concord, North Carolina, 28025
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-18
Study Completion Date2028-02-16

Study Record Updates

Study Start Date2024-09-18
Study Completion Date2028-02-16

Terms related to this study

Keywords Provided by Researchers

  • CD20
  • CD8
  • T cell engager
  • TCR
  • AZD5492
  • Relapsed, Refractory
  • B-cell malignancies
  • CLL, Chronic lymphocytic leukemia
  • SLL, Small lymphocytic lymphoma
  • MCL, Mantle cell lymphoma
  • LBCL, Large B-cell lymphoma
  • FL, Follicular lymphoma
  • TITANium

Additional Relevant MeSH Terms

  • B-cell Malignancies