RECRUITING

A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature 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

The purpose of this study is to assess the safety and efficacy of AZD0486 administered as monotherapy or in combination with other anticancer agents in participants with hematological malignancies.

Official Title

A Phase I/II Open-Label Multi-Centre Master Protocol to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or in Combination With Other Anticancer Agents in Participants With Mature B-Cell Malignancies

Quick Facts

Study Start:2025-01-30
Study Completion:2031-04-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06564038

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. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  2. * Contraception during treatment and at least 6 months after final dose.
  3. * Confirmed CD19 expression if prior anti-CD19 therapy.
  1. * central nervous system (CNS) lymphoma.
  2. * Surgery within 14 days of study drug.
  3. * Clinically significant cardiovascular (CV) disease.
  4. * Unresolved Grade \>2 AEs from prior anticancer therapy (except alopecia or fatigue).
  5. * Any anticancer therapy within 5 half-lives or 21 days (whichever is shorter) prior to treatment.
  6. * Radiation therapy within 28 days.
  7. * Prior CAR-T or auto-haematopoietic stem cell transplant (HSCT) within 12 weeks or prior T-cell engager (TCE) within 8 weeks.
  8. * Prior Grade \> 3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) event.

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Research Site
Boston, Massachusetts, 02215
United States
Research Site
New Brunswick, New Jersey, 08901
United States
Research Site
New York, New York, 10029
United States
Research Site
Charlotte, North Carolina, 28204
United States
Research Site
Portland, Oregon, 97239
United States
Research Site
Philadelphia, Pennsylvania, 19104
United States
Research Site
Providence, Rhode Island, 02903
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 Date2025-01-30
Study Completion Date2031-04-25

Study Record Updates

Study Start Date2025-01-30
Study Completion Date2031-04-25

Terms related to this study

Keywords Provided by Researchers

  • IgG4 fully human CD19xCD3 bispecific T-cell engager
  • B cell lymphoma
  • Subcutaneous
  • AZD0486
  • Acalabrutinib
  • Prednisone
  • Rituximab
  • Cyclophosphamide
  • Vincristine
  • Doxorubicin

Additional Relevant MeSH Terms

  • Chronic Lymphocytic Leukaemia
  • Small Lymphocytic Leukaemia
  • Mantle-cell Lymphoma
  • Large B-cell Lymphoma
  • B-cell Non-Hodgkin Lymphoma