Phase 1 Leukaemia Trial, Recruiting NCT06656494 Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. Condition: Leukaemia
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Phase 1 Leukaemia Trial, Recruiting

NCT06656494
Recruiting Phase 1 🇦🇺 Australian site

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 a type of blood cancer called AML (but not a specific subtype called APL) or MDS, confirmed using standard medical guidelines.
  • If you have AML and have already received treatment that did not work or stopped working, you may be eligible.
  • If you have AML and have never been treated before, you must be either 60 years of age or older, OR between 18 and 59 years old with certain health conditions that make standard intensive chemotherapy unsuitable for you (confirm with trial site).
  • If you have MDS (either newly diagnosed or previously treated and not responding), your disease must be rated as higher risk using a standard scoring system, and you must have at least 5% abnormal cells in your bone marrow (confirm with trial site).
  • Doctors expect you to live for at least 12 weeks or more.
  • Your kidneys must be working well enough, as measured by a standard kidney function test.
  • Your liver must be functioning at an adequate level.

Who may not be able to join:

  • You have a form of AML or MDS that did not respond to, or you could not tolerate, certain specific prior treatments (azacitidine or BCL-2 inhibitor drugs) (confirm with trial site).
  • You have been diagnosed with the specific AML subtype called acute promyelocytic leukemia (APL).
  • The blood cancer has spread to your brain or spinal cord.
  • You currently have an active hepatitis B or hepatitis C infection.
  • You have a history of a weakened immune system, or you have tested positive for HIV.
  • You have had another type of cancer in the past 2 years, unless it was fully cured with treatment.

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 2 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.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Registry
ClinicalTrials.gov
Start date
18 December 2024
Est. completion
1 June 2027

Where this trial is recruiting

🇦🇺 Australia 🇨🇳 China 🇺🇸 United States

2 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Incidence, type, and severity of dose-limiting toxicity (DLT).; Recommended phase II dose (RP2D) and/or maximum tolerated dose (MTD).; The incidence, nature, and severity of adverse events (AEs) as assessed per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0) criteria.; AML cohort:Composite complete remission rate by Investigator per ELN 2017 criteria.; AML cohort:Composite complete remission rate by completion of cycle 2 by Investigator per ELN 2017 criteria.; MDS cohort:mOR rate, including CR, mCR, and PR, assessed by Investigator at any time point du...

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: 2 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