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

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Chronic Lymphocytic Leukaemia
Intervention / Treatment

-

Contacts and Locations

Boston

Research Site, Boston, Massachusetts, United States, 02215

New Brunswick

Research Site, New Brunswick, New Jersey, United States, 08901

New York

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

Charlotte

Research Site, Charlotte, North Carolina, United States, 28204

Portland

Research Site, Portland, Oregon, United States, 97239

Philadelphia

Research Site, Philadelphia, Pennsylvania, United States, 19104

Providence

Research Site, Providence, Rhode Island, United States, 02903

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

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2031-04-25