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New treatment option for R/R AML
Official title First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelodysplastic Syndrome (HR-MDS)
ClinicalTrials.gov ID: NCT07384715
What this study is testing
What is GEN3018?
GEN3018 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for r/r aml.
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
- The drug that will be investigated in the trial is an antibody, GEN3018. Since this is the first trial of GEN3018 in humans, the main purpose is to evaluate safety.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
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
- Key All Participants:
- Be at least 18 years of age at the time of signing informed consent form (ICF).
- Participant's life expectancy at screening is judged to be at least 3 months.
- Must have fresh bone marrow samples collected at screening.
- Bone marrow (BM) blasts ≥ 5% at screening.
You likely can't join if
- All Participants:
- Diagnosis of acute promyelocytic leukemia (APL).
- Presence of extramedullary AML at screening.
- Prior autologous or allogenic hematopoietic stem cell transplant (HSCT) within 3 months prior to initiation of trial treatment.
- Active graft-versus-host disease.
- History of severe immune-related adverse events.
See the full eligibility criteria
- Key All Participants:
- Be at least 18 years of age at the time of signing informed consent form (ICF).
- Participant's life expectancy at screening is judged to be at least 3 months.
- Must have fresh bone marrow samples collected at screening.
- Bone marrow (BM) blasts ≥ 5% at screening.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2.
- Has acceptable laboratory test results during the screening period Participants with R/R AML:
- Relapsed or refractory AML, either de novo or secondary, and must have failed all conventional therapies.
- Relapsed or refractory to at least one prior line of therapy. Participants with R/R HR-MDS:
- Diagnosed with high- or very-high risk MDS according to International Prognostic Scoring System (IPSS-R) (score of \> 4.5 ie, high or very high) or World Health Organization (WHO) 2022 classification (ie, MDS-IB1 or...
- Refractory or relapsed after hypomethylating agents (HMAs) (such as azacitidine or decitabine). Key
- All Participants:
- Diagnosis of acute promyelocytic leukemia (APL).
- Presence of extramedullary AML at screening.
- Prior autologous or allogenic hematopoietic stem cell transplant (HSCT) within 3 months prior to initiation of trial treatment.
- Active graft-versus-host disease.
- History of severe immune-related adverse events.
- Treatment with anti-cancer agent (eg, small molecule, antibody, chemotherapy, radiation therapy), or major surgery within 2 weeks prior to the first dose of GEN3018. Other protocol-defined Inclusion and Exclusion...
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Denmark
- Copenhagen, Denmark
- Barcelona, Spain
- Madrid, Spain
- Valencia, Spain
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 Aarhus, Denmark; Copenhagen, Denmark; Barcelona, Spain; Madrid, Spain; Valencia, Spain. 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.