Phase 1 Leukaemia Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with acute myeloid leukemia (AML), confirmed by a lab test on a tissue or bone marrow sample.
- Your AML has come back for a second time or more, OR it has not responded to at least two different treatment attempts.
- A lab test (called flow cytometry) has shown that your leukemia cells have a specific marker called CD123 on their surface.
- At least 5% of your bone marrow cells are leukemia cells at the time your disease returned or stopped responding to treatment.
- You are well enough to carry out some daily activities, based on a standard health/functioning score used by doctors (confirm with trial site for exact score details).
- Your leukemia may have spread to the fluid around the brain and spine, as long as you are not having obvious symptoms from it (such as facial drooping, eye problems, or hormone-related symptoms).
- If you are a child who cannot legally consent for yourself, a parent or legal guardian must be willing and able to give consent on your behalf.
Who may not be able to join:
- You have a known serious heart condition.
- You have Down syndrome.
- Your leukemia is a specific type called acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML).
- You have active, symptomatic leukemia in the fluid around your brain and spine that is causing noticeable symptoms.
- You have ever had a serious liver condition involving blocked blood vessels in the liver (called veno-occlusive disease or sinusoidal obstructive syndrome).
- You had a stem cell transplant less than 6 months ago, or you are still taking medicines to prevent transplant rejection or a complication called graft-versus-host disease (other than a steady low dose of steroids).
- You have previously received a type of treatment called CAR-T cell therapy.
- You currently have another type of cancer that requires treatment.
- You are currently receiving any other cancer treatment (such as chemotherapy, radiation, targeted drugs, or experimental therapies), except for treatment given directly into the spinal fluid.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: ABBVIE INC., AbbVie
Phone: 844-663-3742
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation; Maximum Observed Serum/Plasma Concentration (Cmax) of Intact Antibody-Drug Conjugate (ADC); Cmax of FGN849 Payload; Area Under the Concentration-Time Curve (AUC) of Intact ADC; AUC of FGN849 payload; Time to Cmax (Tmax) of Intact ADC; Tmax of FGN849 Payload
Can't join this trial?
Data last synced from ClinicalTrials.gov: 5 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.