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Tests treatment safety and results for Acute Myeloid Leukemia, Adult
Official title First-in-human Study Aiming to Characterize the Safety, Tolerability, Pharmacokinetic and Preliminary Signs of Activity of ABD-3001 in Refractory or Relapsed AML and High Risk MDS Adult Patients
ClinicalTrials.gov ID: NCT05601726
What this study is testing
What is ABD-3001?
ABD-3001 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myeloid leukemia, adult.
Also referred to as DIMATE.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This First In Human (FIH) study is a prospective, open-label, multicenter, Phase 1 study, with a dose escalation design, followed by an optimized design. It will consist in a Single Ascending Dose (SAD) part and a Multiple Ascending Dose (MAD) part.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with relapsed/refractory Acute Myeloid Leukemia (AML) after failing at least one therapy regimen and a salvage treatment or are not eligible...
- Patients with relapsed/refractory Myelodysplastic syndrome (MDS) ineligible for salvage treatment who are diagnosed high-risk and very high-risk...
- Patients not eligible to alloSCT
- Negative blood or serum/urine pregnancy test
You likely can't join if
- Patients with acute myeloid leukemia (AML) with Inv(16) MYH11-CBF-Beta or t(8;21) AML-ETO RUNX1-RUNX1 or (PML/RARA) karyotype abnormalities and...
- Participants with clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia
- Ongoing immunosuppressive treatment
- Hematopoietic stem cell transplantation (HSCT) performed within 3 months prior to study Visit 1
- Active infection requiring intravenous anti-infectious treatment during the screening period
- Life-threatening illnesses other than the studied one, uncontrolled medical conditions or organ system dysfunction which, in the investigator's...
See the full eligibility criteria
- Patients with relapsed/refractory Acute Myeloid Leukemia (AML) after failing at least one therapy regimen and a salvage treatment or are not eligible for salvage treatment regimens including targeted therapy
- Patients with relapsed/refractory Myelodysplastic syndrome (MDS) ineligible for salvage treatment who are diagnosed high-risk and very high-risk using Revised International Prognostic Scoring System (IPSS-R) prognostic...
- Patients not eligible to alloSCT
- Negative blood or serum/urine pregnancy test
- Patients with acute myeloid leukemia (AML) with Inv(16) MYH11-CBF-Beta or t(8;21) AML-ETO RUNX1-RUNX1 or (PML/RARA) karyotype abnormalities and eligible to targeted therapies
- Participants with clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia
- Ongoing immunosuppressive treatment
- Hematopoietic stem cell transplantation (HSCT) performed within 3 months prior to study Visit 1
- Active infection requiring intravenous anti-infectious treatment during the screening period
- Life-threatening illnesses other than the studied one, uncontrolled medical conditions or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety or interfere with the...
- Anti-tumor therapy within 14 days of study Visit 1
- Prior participation in an treatment investigational clinical study (drug or medical device) within 21 days of study Visit 1
- Radiotherapy within 28 days prior to study Visit 1
- Current history of seropositivity to human immunodeficiency virus (HIV) or infection with active hepatitis C virus (HCV) or active hepatitis B virus (HBV) or active SARS-CoV-2 (Covid-19) or Syphilis, or Cytomegalovirus...
- History of other malignancy in the last 12 months prior to study Visit 1
- Other active solid tumor
- people with New York Heart Association (NYHA) Class III or IV congestive heart failure or Left Ventricular Ejection Fraction (LVEF) \<50% attested by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan within...
- people with a history of myocardial infarction within the last 3 months prior to study Visit 1 (Day 1, start of study therapy)
- people with heart-rate corrected QT (QTc) interval ≥450 ms or other factors that increase the risk of QT prolongation or arrhythmic events
- Major surgery within 4 weeks prior to study Visit 1 (Day 1, start of study therapy)
- Any condition deemed by the investigator to be likely to interfere with a subject's ability to participate in the clinical trial MAD specific exclusion criteria: Patients who have been part of SAD and have experienced a...
The study team makes the final eligibility decision.
Where it's taking place
- Marseille, France, France
- Paris, France, France
- Pierre-Bénite, France, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Marseille, France, France; Paris, France, France; Pierre-Bénite, France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.