OncoMatch/Clinical Trials/NCT06137118
AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia
Is NCT06137118 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies AZD0486 for b-cell acute lymphoblastic leukemia (b-all).
Treatment: AZD0486 — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 expression
B-cell Acute Lymphoblastic Leukemia with CD19 expression by local lab
Allowed: ABL1 fusion
Philadelphia positive participants are allowed in all parts of the study, if intolerant or refractory to TKIs
Performance status
ECOG/LANSKY 0–2
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%.
Prior therapy
Must have received:
Either relapsed or refractory after a minimum of 2 prior therapies or after 1 prior line of therapy if no SOC available option
Cannot have received: T-cell engager
Prior therapy with TCEs within 4 weeks
Cannot have received: CAR-T cell therapy
CAR T-cell therapy or autologous HSCT within 8 weeks
Cannot have received: autologous stem cell transplant
CAR T-cell therapy or autologous HSCT within 8 weeks
Cannot have received: allogeneic stem cell transplant
prior alloSCT within 12 weeks of start of therapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Research Site · Birmingham, Alabama
- Research Site · Duarte, California
- Research Site · Los Angeles, California
- Research Site · Palo Alto, California
- Research Site · Tampa, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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