OncoMatch

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).

Phase 1/2RecruitingAstraZenecaNCT06137118Data as of May 2026

Treatment: AZD0486This 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 qualify

Extracted 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

Min 2 prior lines

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 →

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify