Recruiting NCT06137118

AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

Phase I / Phase II Interventional B-cell Acute Lymphoblastic Leukemia (B-ALL)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: AZD0486.
Who it may be relevant to: Registry conditions: B-cell Acute Lymphoblastic Leukemia (B-ALL). Basic parameters: from 12 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Brazil, Canada, China +8
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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)

Detailed description

This dose escalation and optimization study is evaluating the safety, tolerability, PK, PD and clinical activity of AZD0486 monotherapy in r/r B-ALL.

Interventions

Drug AZD0486
Investigational Product administered via intravenous infusion.

Primary outcome measures

Part A: Frequency of DLTs [Time frame: Up to 28 days]
Parts A & B: Safety Evaluation of AZD0486 [Time frame: From signing of informed consent through data cutoff, up to 42 months]
Parts B & C: Rate of CR within 3 cycles [Time frame: Up to three cycles of 28 days each]

Secondary outcome measures (12)

Part A: Rate of CR within 3 cycles [Time frame: Up to 3 cycles of 28 days each]
Part A,B,C: Rate of CR/CRh and CR/CRh/CRi within 3 cycles [Time frame: Up to 3 cycles of 28 days each]
Parts A, B, C: Rate of CR, CR/CRh and CR/CRh/CRi at any time during the study [Time frame: From first dose to end of treatment or data cutoff, whichever comes first, assessed up to 42 months]
Parts A, B, C: Duration of CR, CR/CRh and CR/CRh/CRi [Time frame: From first dose to last progression or data cutoff, whichever comes first, assessed up to 42 months]
Parts A, B, C: Event-free survival (EFS) [Time frame: From First dose to last progression or data cutoff, whichever comes first, assessed up to 42 months]
Parts A, B, C: Overall Survival (OS) [Time frame: From First dose to data cutoff, up to 42 months]
Parts B &C: Subsequent alloSCT or donor lymphocyte infusion if used as an alloSCT substitute [Time frame: From first dose to EOT, up to 42 Months]
Part A, B, C:MRD-negative rate of CR [Time frame: From First dose to data cutoff, up to 42 months]
Parts A, B, & C: PK characterization of AZD0486 [Time frame: From first dose to data cutoff, up to 42 months]
Parts A, B & C: PK Characterization of AZD0486 [Time frame: From first dose to data cutoff, up to 42 months]
Parts A, B, C: PK Characterization of AZD0486 [Time frame: From first dose to data cutoff, up to 42 months]
Parts A, B, C: PK Characterization of AZD0486 [Time frame: From first dose to data cutoff, up to 42 months]

Eligibility criteria

Inclusion criteria

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%.

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).
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.

The above is a summary, other exclusion criteria details may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Sequential
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 12 centers

Research Site — Birmingham
Research Site — Duarte
Research Site — Los Angeles
Research Site — Palo Alto
Research Site — Tampa
Research Site — Atlanta
Research Site — Chicago
Research Site — New York
… and 4 more centers

Germany · 11 centers

Research Site — Cologne
Research Site — Düsseldorf
Research Site — Essen
Research Site — Frankfurt
Research Site — Freiburg im Breisgau
Research Site — Halle
Research Site — Hamburg
Research Site — Kiel
… and 3 more centers

Japan · 11 centers

Research Site — Bunkyō City
Research Site — Chiba
Research Site — Chūōku
Research Site — Fukuoka
Research Site — Kashiwa
Research Site — Kyoto
Research Site — Okayama
Research Site — Osaka
… and 3 more centers

China · 10 centers

Research Site — Changsha
Research Site — Chengdu
Research Site — Guangzhou
Research Site — Guangzhou
Research Site — Hangzhou
Research Site — Nanjing
Research Site — Nanjing
Research Site — Suzhou
… and 2 more centers

France · 6 centers

Research Site — Caen
Research Site — Marseille
Research Site — Nantes
Research Site — Paris
Research Site — Pierre-Bénite
Research Site — Toulouse

Spain · 6 centers

Research Site — Barcelona
Research Site — Barcelona
Research Site — Madrid
Research Site — Madrid
Research Site — Salamanca
Research Site — Valencia

Italy · 5 centers

Research Site — Bergamo
Research Site — Bologna
Research Site — Monza
Research Site — Naples
Research Site — Roma

Taiwan · 5 centers

Research Site — Kaohsiung City
Research Site — Taichung
Research Site — Tainan
Research Site — Taipei
Research Site — Taoyuan

South Korea · 4 centers

Research Site — Seoul
Research Site — Seoul
Research Site — Seoul
Research Site — Seoul

Brazil · 3 centers

Research Site — Porto Alegre
Research Site — São Paulo
Research Site — São Paulo

Canada · 3 centers

Research Site — Toronto
Research Site — Montreal
Research Site — Montreal

United Kingdom · 3 centers

Research Site — London
Research Site — Manchester
Research Site — Surrey

Australia · 1 center

Research Site — Melbourne

Publications

Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067. PMID 41671463

Identifiers

NCT: NCT06137118 · D7405C00001

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗