NCT06137118 AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia
| NCT ID | NCT06137118 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | AstraZeneca |
| Condition | B-cell Acute Lymphoblastic Leukemia (B-ALL) |
| Study Type | INTERVENTIONAL |
| Enrollment | 255 participants |
| Start Date | 2023-12-29 |
| Primary Completion | 2028-02-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 255 participants in total. It began in 2023-12-29 with a primary completion date of 2028-02-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a Phase 1/2, global multicentre, open-label, single-arm, dose escalation and dose optimization study of surovatamig (AZD0486) to evaluate the safety, tolerability, and efficacy of surovatamig (AZD0486) monotherapy in participants with R/R B ALL. The study will consist of 4 parts. Part A: monotherapy dose escalation in 3L+ B-ALL. Part B: dose optimization in 3L+ B-ALL. Part C: Dose expansion in 3L+ B-ALL. Part D: Dose optimization and efficacy expansion in R/R B-ALL (2L+)
Eligibility Criteria
Inclusion Criteria: * Age: 12 years and above (Parts A, B, C and D). * 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 (Parts A, B, C); or relapsed or refractory to ≥1 prior line of therapy (Part D). 3. 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%. The above is a summary, other inclusion criteria details may apply. Exclusion Criteria: * Active CNS involvement by B-ALL, defined by presence of ALL blasts in CSF (CNS2 and CNS3 criteria), or signs of CNS involvement. * 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 ADCs within 3 weeks, 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. The above is a summary, other exclusion criteria details may apply.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06137118 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying B-cell Acute Lymphoblastic Leukemia (B-ALL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06137118 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06137118 currently recruiting?
Yes, NCT06137118 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT06137118 trial being conducted?
This trial is being conducted at Birmingham, United States, Duarte, United States, Los Angeles, United States, Palo Alto, United States and 11 additional locations.
Who is sponsoring the NCT06137118 clinical trial?
NCT06137118 is sponsored by AstraZeneca. The trial plans to enroll 255 participants.
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