Phase 1 Leukaemia Trial, Recruiting NCT07384715 Sponsor: Genmab Condition: Leukaemia
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Phase 1 Leukaemia Trial, Recruiting

NCT07384715
Recruiting Phase 1

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:

  • People who are at least 18 years old at the time of signing the consent form
  • People whose doctors judge them to have a life expectancy of at least 3 months at the time of screening
  • People who are able to provide a fresh bone marrow sample at screening
  • People whose bone marrow contains at least 5% blast cells (a type of abnormal cell) at screening
  • People who have a physical functioning score of 2 or lower on a standard scale used by doctors to measure how well a person can carry out daily activities (confirm with trial site)
  • People whose blood and other lab test results fall within acceptable ranges during the screening period
  • People with relapsed or refractory AML (a type of blood cancer that has come back or stopped responding to treatment) — either a new diagnosis or one that developed from another condition — who have already tried all standard treatments
  • People with AML that has relapsed or not responded to at least one prior round of treatment
  • People diagnosed with high-risk or very-high-risk MDS (a bone marrow disorder) based on specific medical scoring systems used by doctors (confirm with trial site)
  • People with MDS whose condition has not responded to, or has come back after, treatment with a type of drug called hypomethylating agents (such as azacitidine or decitabine)

Who may not be able to join:

  • People diagnosed with a specific subtype of blood cancer called acute promyelocytic leukemia (APL)
  • People whose AML has spread outside the bone marrow at the time of screening
  • People who have had a stem cell transplant (using their own or a donor's cells) within the 3 months before starting trial treatment
  • People who currently have an active condition called graft-versus-host disease (a complication that can follow a stem cell transplant)
  • People who have a history of severe immune-related side effects from previous treatments
  • People who have received anti-cancer treatment — such as chemotherapy, targeted drugs, antibody treatments, or radiation — or who have had major surgery within 2 weeks before the first dose of the trial drug

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Study Official, Genmab

Phone: +4570202728

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

Status
Recruiting
Phase
Phase 1
Sponsor
Genmab
Registry
ClinicalTrials.gov
Start date
16 February 2026
Est. completion
18 October 2029

Where this trial is recruiting

🇩🇰 Denmark 🇪🇸 Spain

Primary endpoints

Part 1: Number of Participants with Dose-limiting Toxicities (DLTs); Parts 1 and 2: Number of Participants with Adverse Events (AEs)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov