AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia
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
AstraZeneca
163 participants
Dec 29, 2023
INTERVENTIONAL
Conditions
Summary
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)
Eligibility
Inclusion Criteria6
- Age: 12 years and above (Parts A, B and C).
- Participants with B-cell Acute Lymphoblastic Leukemia with CD19 expression by local lab with:
- Bone marrow infiltration with \>/= 5% blasts
- Either relapsed or refractory after a minimum of 2 prior therapies or after 1 prior line of therapy if no SOC available option.
- Philadelphia positive participants are allowed in all parts of the study, 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%.
Exclusion Criteria8
- 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.
Interventions
Investigational Product administered via intravenous infusion.
Locations(79)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06137118