Recruiting
Phase 1

Pivekimab Sunirine

Sponsor:

AbbVie

Code:

NCT07306832

Conditions

Acute Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Pivekimab Sunirine

Study Details

Brief summary:

Acute myeloid leukemia (AML) is an aggressive blood cancer, withwith few options for participants who relapse after treatment or who don't respond to treatment. This study will assess the adverse events and how pivekimab sunirine moves through the body in pediatric participants with relapsed or refractory (R/R) AML.

Pivekimab sunirine is a drug being evaluated in the treatment of AML. This is an open label, single arm study, participants will be enrolled in 1 of the 3 cohorts based on their age and will receive pivekimab sunirine at a dose based on their weight. Around 18 pediatric participants with a diagnosis of AML will be enrolled in the study at approximately 30 sites around the world.

Participants will receive intravenous (IV) pivekimab sunirine alone. The total study duration is approximately 28 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.

Conditions

Acute Myeloid Leukemia

Study ID

NCT07306832

Start date

May 20, 2026

Status verified date

Aug, 2026

Completion date

Mar, 2030

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Must have histologically confirmed acute myeloid leukemia (AML) meeting one of the following disease criteria:

  • Second or greater relapse. OR
  • Disease refractory to second or subsequent line of therapy (defined as resistant disease after at least one cycle of each treatment regimen).
  • Must have myeloid leukemic blasts that are CD123-positive by flow cytometry as determined by the treating institution.
  • Has >= 5% myeloid leukemic blasts in bone marrow at time of relapse or refractory disease and prior to Screening for this study.
  • Performance status by Lansky (< 16 years old at evaluation) or Karnofsky (>= 16 years old at evaluation) score >= 50 or ECOG score <= 2.
  • May have status of central nervous system (CNS)1, CNS2, or CNS3 disease without clinical signs or neurologic symptoms suggestive of CNS leukemia, such as facial nerve palsy, brain/eye involvement or hypothalamic syndrome. Participants receiving intrathecal therapy and no additional CNS-directed systemic therapy at study entry are eligible and may continue treatment as clinically indicated in accordance with institutional practice.
  • For those participants who have not reached the age of consent, parent or legal guardian with the willingness and ability to provide informed consent and participant willing and able to give assent, as appropriate for age and country.

Exclusion Criteria:

  • Known clinically significant cardiac disease.
  • Down syndrome.
  • Acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML).
  • Symptomatic central nervous system (CNS3) disease
  • Prior history of any severity veno-occlusive disease/sinusoidal obstructive syndrome (VOD/SOS) of the liver.
  • Prior history of hematopoietic stem cell transplant within 6 months prior to Screening without evidence of active GvHD at the time of screening and the participant is off medications to treat or prevent either post-transplant graft-versus-host disease (GvHD) or post-transplant rejection (except for a stable dose of corticosteroids).
  • Have received prior Chimeric Antigen Receptor T-cell (CAR-T) therapy.
  • Any other known current malignancy requiring therapy.
  • Currently receiving anticancer therapy with antineoplastic intent, including radiotherapy, systemic therapy small molecules, monoclonal antibodies, other investigational agents, or high-dose chemotherapy with the exception of intrathecal therapy.

Study Design

Enrollment

18 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1: Pivekimab Sunirine Ages 2 to < 6 Years

Participants will receive pivekimab sunirine, as part of the approximately 28 month study duration. If enrolled, subjects aged 6 months to less than 2 years will be included in Cohort 1

experimental: Cohort 2: Pivekimab Sunirine Ages 6 to < 12 Years

Participants will receive pivekimab sunirine, as part of the approximately 28 month study duration.

experimental: Cohort 3: Pivekimab Sunirine Ages 12 to < 17 Years

Participants will receive pivekimab sunirine, as part of the approximately 28 month study duration.

Interventions

Pivekimab Sunirine

Intravenous

Primary outcome measure

  • Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation [ Time Frame: Up to Approximately 24 Months ]
  • Maximum Observed Serum/Plasma Concentration (Cmax) of Intact Antibody-Drug Conjugate (ADC) [ Time Frame: Up to Approximately 22 Months ]
  • Cmax of FGN849 Payload [ Time Frame: Up to Approximately 22 Months ]
  • Area Under the Concentration-Time Curve (AUC) of Intact ADC [ Time Frame: Up to Approximately 22 Months ]
  • AUC of FGN849 payload [ Time Frame: Up to Approximately 22 Months ]
  • Time to Cmax (Tmax) of Intact ADC [ Time Frame: Up to Approximately 22 Months ]
  • Tmax of FGN849 Payload [ Time Frame: Up to Approximately 22 Months ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Lucile Packard Children's Hospital /ID# 276015

Recruiting

Palo Alto, California, United States, 94304

New York Medical College /ID# 275597

Recruiting

Valhalla, New York, United States, 10595

Tristar Centennial Medical Center /ID# 275831

Recruiting

Nashville, Tennessee, United States, 37203

Children's Medical Center Dallas /ID# 275930

Recruiting

Dallas, Texas, United States, 75235

More Information

Sponsor

AbbVie

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Acute Myeloid Leukemia
  • Relapsed
  • Refractory
  • Pivekimab Sunirine
  • PVEK
  • Pediatric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AbbVie on 2026-08-27.