AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

Description

This is a Phase 1/2, global multicentre, open-label, single-arm, dose escalation and dose optimisation study of AZD0486 to evaluate the safety, tolerability, and efficacy of AZD0486 monotherapy in participants with R/R B ALL who have received ≥ 2 prior lines of therapies. The study will consist of 3 parts. Part A monotherapy dose escalation. Part B dose optimisation. Part C Dose expansion at the recommended phase 2 dose (RP2D)

Conditions

B-cell Acute Lymphoblastic Leukemia (B-ALL)

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Study Overview

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Study Details

Study overview

This is a Phase 1/2, global multicentre, open-label, single-arm, dose escalation and dose optimisation study of AZD0486 to evaluate the safety, tolerability, and efficacy of AZD0486 monotherapy in participants with R/R B ALL who have received ≥ 2 prior lines of therapies. The study will consist of 3 parts. Part A monotherapy dose escalation. Part B dose optimisation. Part C Dose expansion at the recommended phase 2 dose (RP2D)

A Phase 1/2 Study to Evaluate the Safety and Efficacy of AZD0486 in Adolescent and Adult Participants With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukaemia

AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

Condition
B-cell Acute Lymphoblastic Leukemia (B-ALL)
Intervention / Treatment

-

Contacts and Locations

Birmingham

Research Site, Birmingham, Alabama, United States, 35233

Duarte

Research Site, Duarte, California, United States, 91010

Los Angeles

Research Site, Los Angeles, California, United States, 90048

Palo Alto

Research Site, Palo Alto, California, United States, 94304

Tampa

Research Site, Tampa, Florida, United States, 33612

Atlanta

Research Site, Atlanta, Georgia, United States, 30322

Chicago

Research Site, Chicago, Illinois, United States, 60637

New York

Research Site, New York, New York, United States, 10016

Houston

Research Site, Houston, Texas, United States, 77030

Richmond

Research Site, Richmond, Virginia, United States, 23298

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

  • * Age: 16 years and older (Part A), 12 years and older (Parts B and C).
  • * Participants with B-cell Acute Lymphoblastic Leukemia with CD19 expression by local lab with:
  • 1. Bone marrow infiltration with \>/= 5% blasts
  • 2. Either relapsed or refractory after a minimum of 2 prior therapies or after 1 prior line of therapy if no SOC available option.
  • 3. Philadelphia positive participants are allowed in Part A if intolerant or refractory to TKIs.
  • * For participants older than 16 years, Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2. For Participants 16 years or younger, Lansky score more or equal to 50%.
  • * Active CNS involvement by B-ALL, defined by presence of ALL blasts in CSF (CNS2 and CNS3 criteria).
  • * Isolated extramedullary disease relapse.
  • * Testicular leukemia
  • * History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis; or prior Grade 4 neurotoxicity with CAR-T or TCE therapy.
  • * History of other malignancy (with certain exceptions).
  • * Unresolved AEs \>/= Grade 2, from prior therapies
  • * Prior therapy with TCEs within 4 weeks, CAR T-cell therapy or autologous HSCT within 8 weeks or prior alloSCT within 12 weeks of start of therapy.
  • * GVHD requiring immunosuppressive therapy within 3 weeks prior to AZD0486 treatment.

Ages Eligible for Study

12 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2027-06-29