Early Phase 1 Leukaemia Trial, Recruiting NCT06762132 Sponsor: Zhejiang University Condition: Leukaemia
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Early Phase 1 Leukaemia Trial, Recruiting

NCT06762132
Recruiting Early 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, of any gender
  • People for whom CAR-T cells can be successfully prepared, or whose own CAR-T cell preparation has failed (for example, because there were not enough lymphocytes, the cells did not grow sufficiently, or the cells could not be given back)
  • People diagnosed with acute myeloid leukemia (AML) — a type of blood cancer — where lab tests confirm that more than 80% of the cancer cells carry a marker called CD33
  • People whose AML is classified as relapsed (the cancer came back after going into remission) or refractory (the cancer did not respond well enough to standard treatments), according to specific Chinese clinical guidelines, and for whom no other suitable standard treatments or eligible registered clinical trials are currently available
  • People whose bone marrow tests show a certain minimum level of immature cancer cells (confirm with trial site for exact thresholds)
  • People whose liver and kidney function blood test results fall within acceptable ranges (confirm with trial site for exact values)
  • People whose heart scan shows the heart is pumping at least 50% effectively
  • People who have no active lung infection and whose blood oxygen level while breathing normal air is above 92%
  • People whose life expectancy is estimated to be more than 3 months
  • People with a general health and physical functioning score rated 0 to 2 on a standard medical scale (meaning able to carry out everyday activities with at most moderate limitations)
  • People who are pregnant, breastfeeding, or of childbearing or fathering potential, who are willing to use effective contraception throughout the study and for at least 6 months after the last cell treatment
  • People who voluntarily agree to participate and sign a consent form

Who may not be able to join:

  • People with a history of epilepsy or other brain or nervous system conditions
  • People with a prolonged QT interval (a specific heart rhythm measurement) or serious heart disease
  • People who currently have an active infection that has not been successfully treated
  • People with an active hepatitis B or hepatitis C infection
  • People who have previously received any gene therapy treatment
  • People whose immune cells show a poor growth response in laboratory testing (confirm with trial site for exact details)
  • People who have another uncontrolled medical condition that the trial doctors consider makes participation unsuitable
  • People who are infected with HIV (the virus that causes AIDS)
  • People with any other situation that trial doctors believe could increase risk or affect the reliability of the trial results

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 19 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

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

Phone: 057187233772

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
Early Phase 1
Sponsor
Zhejiang University
Registry
ClinicalTrials.gov
Start date
10 January 2025
Est. completion
30 October 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Dose-limiting toxicity (DLT); Incidence of treatment-emergent adverse events (TEAEs)

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: 19 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