A trial to understand if AZD0486 is safe and helps in people with Relapsed or Refractory B-cell acute lymphoblastic leukemia (B-ALL)

Phase 1

• Conditions: B-Cell Acute Lymphoblastic Leukaemia; Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]

• Registration Number: CTIS2023-505840-20-00
• Lead Sponsor: Astrazeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-21
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

Age: 16-80 years old (Part A), 12-80 years old (Parts B and C)., Participants with CD19+ B-cell Acute Lymphoblastic Leukemia by local lab with Bone marrow infiltration with >/= 5% blasts, Participants with CD19+ B-cell Acute Lymphoblastic Leukemia by local lab with Either relapsed or refractory after a minimum of 2 prior therapies or after 1 prior line of therapy if no SOC available option., Participants with CD19+ B-cell Acute Lymphoblastic Leukemia by local lab with Philadelphia positive participants are allowed in Part A if intolerant or refractory to TKIs., Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2 OR Lansky score more or equal to 50%.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified