Phase 2 Leukaemia Trial, Recruiting NCT06680752 Sponsor: ARCE Therapeutics, Inc. Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT06680752
Recruiting Phase 2

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 AML (a type of blood cancer) that has either not responded to treatment or has come back, OR you have been diagnosed with MDS (a bone marrow disorder) with at least 5% abnormal cells in your bone marrow
  • You are generally well enough to carry out light activity and care for yourself (this is measured on a standard 0–1 scale used by doctors)
  • You have a sufficient level of certain white blood cells in your blood
  • Your kidneys, liver, and heart are working well enough to meet specific medical thresholds (confirm with trial site)
  • If you are a woman who could become pregnant, you must have a negative pregnancy test before joining
  • Both men and women who could have children must agree to use an effective form of birth control during the trial
  • You are able to understand and sign a consent form agreeing to take part

Who may not be able to join:

  • You have a specific type of leukemia called acute promyelocytic leukemia (APL)
  • You have an active and significant condition affecting your brain or nervous system
  • You have an autoimmune disease (where your immune system attacks your own body) that requires medication to suppress your immune system
  • You have been diagnosed with severe liver scarring (a condition called hepatic bridging cirrhosis)
  • You currently have an active hepatitis B or C infection
  • You have previously received a gene therapy or cell therapy (including CAR-T cell therapy)
  • You currently have active graft-versus-host disease (a complication sometimes seen after transplants) or are taking more than 10 mg of prednisone (or a similar steroid medication) daily
  • You have received chemotherapy, targeted therapy, or other cancer-directed treatments within the 14 days before screening, or are receiving them during the study

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 22 July 2026
Phase 2: approximately ~30% 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

Phone: +886-2-26581868

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 2
Sponsor
ARCE Therapeutics, Inc.
Registry
ClinicalTrials.gov
Start date
20 May 2025
Est. completion
1 October 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]; To determine the RP2D of ARD103; To evaluate overall response rate (ORR)

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: 22 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