Phase 1 Leukaemia Trial, Recruiting NCT06027853 Sponsor: Zhejiang University Condition: Leukaemia
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Phase 1 Leukaemia Trial, Recruiting

NCT06027853
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 18 or older
  • People who have been diagnosed with acute myeloid leukaemia (AML) that has come back or stopped responding to previous treatment
  • People whose AML cells test positive for a specific protein called CLL1
  • People who are in reasonably good general health (able to carry out light activity) and are expected to live for more than 12 weeks
  • People whose kidneys are working well enough, based on blood tests
  • People whose liver is working well enough, based on blood tests measuring bilirubin, ALT, and AST levels
  • People whose blood clotting is within an acceptable range, based on INR and aPTT tests
  • Women who could become pregnant must have a negative pregnancy test before joining
  • People who test negative for donor-specific antibodies (a blood test result below a certain level) (confirm with trial site)
  • People who are willing and able to sign a consent form agreeing to take part

Who may not be able to join:

  • People who are allergic to any of the drugs used in this trial
  • People who have had certain cancer treatments too recently before the first infusion, including: systemic steroids within 3 days; most anti-cancer medicines within 2 weeks; radiation therapy within 4 weeks; donor lymphocyte infusion within 6 weeks; treatment injected into the spinal fluid within 1 week; or CAR-T, CAR-NK, or other gene-modified cell therapies within 6 months
  • People who have previously had an allogeneic stem cell transplant (a transplant using cells from another person)
  • People who have received a vaccine within 4 weeks before joining, or who are expected to need a vaccine during the study period or within 12 weeks after the last treatment
  • People whose leukaemia has spread to the brain or spinal fluid (active central nervous system leukaemia)
  • People with a specific type of leukaemia called Acute Promyelocytic Leukaemia (APL)
  • People with a history of another cancer, unless that cancer was fully treated more than 5 years ago with no signs of return
  • People with an active autoimmune disease (where the immune system attacks the body)
  • People with a history of brain or nervous system conditions such as epilepsy, stroke, paralysis, or difficulty speaking
  • People with serious heart or blood vessel problems, including certain abnormal heart rhythms, a recent heart attack, heart failure, stroke, or blood pressure that cannot be controlled with medication
  • People with an active lung infection, low blood oxygen levels, a blood clot in the lungs, chronic obstructive pulmonary disease, or scarring of the lung tissue
  • People with an uncontrolled bacterial, fungal, or viral infection, or who are known to have HIV, active hepatitis B, or active hepatitis C
  • People with a history of substance abuse
  • People who are still experiencing significant side effects from previous treatments that have not sufficiently recovered
  • People who have had major surgery within 4 weeks before the first infusion (not including minor diagnostic procedures such as a biopsy)
  • People who are pregnant or breastfeeding
  • People whom the trial doctors consider to have medical or personal circumstances that could interfere with safe participation in the trial

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

Principal Investigator: He Huang, MD, First Affiliated Hospital of Zhejiang University

Phone: +8613605714822

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
Zhejiang University
Registry
ClinicalTrials.gov
Start date
10 September 2023
Est. completion
31 August 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Incidence of Treatment-Emergent Adverse Events; Incidence of subjects with Dose Limiting Toxicities within each dose level cohort

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