Phase 1 Leukaemia Trial, Recruiting NCT06835140 Sponsor: Chunji Gao Condition: Leukaemia
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Phase 1 Leukaemia Trial, Recruiting

NCT06835140
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 aged between 18 and 70 years old
  • People who have been diagnosed with Acute Myeloid Leukemia (AML) — a type of blood cancer — in a hospital setting
  • People whose AML has stopped responding to multiple standard first-line treatments, or whose disease has come back after initial treatment did not work, and who are expected to live for more than three months
  • People whose AML cells test positive for a protein called CD123, with that protein present on at least 20% of the cancer cells (measured by a lab test called flow cytometry)
  • People who score between 0 and 2 on the ECOG performance scale, or above 80 on the Karnofsky scale — both are ways doctors measure how well a person is able to carry out daily activities (confirm with trial site)
  • People who have a suitable healthy donor available and who agree to allow that donor to give a blood sample

Who may not be able to join:

  • People diagnosed with a specific subtype of AML called Acute Promyelocytic Leukemia (APL)
  • People whose AML cells test negative for CD123, or where CD123 is present on fewer than 20% of cancer cells
  • People who are still experiencing side effects of grade 2 or higher (moderate or worse) from previous treatments, affecting parts of the body other than blood
  • People who need immunosuppressant medicines to manage a serious complication called Graft-Versus-Host Disease (a condition where donated cells attack the body) rated grade II–IV
  • People who have received steroid medicines throughout the body (not creams or inhalers) in the 7 days before the first study treatment, unless it was a short-term preventive dose
  • People who have had serious heart or brain-related medical events in the 6 months before the first dose, have significantly reduced heart function, uncontrolled dangerous heart rhythm problems, or other heart or brain conditions the trial doctor considers unsuitable
  • Women who are pregnant or breastfeeding, as the safety of this treatment for unborn babies is not yet known; a pregnancy test must be negative within 48 hours before treatment
  • People with active Hepatitis B, Hepatitis C, HIV/AIDS, a high level of a virus called CMV in the blood (500 copies/mL or more), or any other active infection that is not under control
  • People who are known to be allergic to immunotherapy treatments or related medicines
  • People with certain neurological (brain or nerve) conditions, such as neurodegenerative diseases, brain tumours or infections, multiple sclerosis, epilepsy, or severe nerve damage

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 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

Phone: +86 13911536256

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
Chunji Gao
Registry
ClinicalTrials.gov
Start date
21 February 2025
Est. completion
31 December 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

ORR; CR; AE

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