Phase 1 Leukaemia Trial, Recruiting NCT05945849 Sponsor: University of Pennsylvania Condition: Leukaemia
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Phase 1 Leukaemia Trial, Recruiting

NCT05945849
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:

  • Adults aged 18 or older
  • People with a type of blood cancer called AML (acute myeloid leukemia) that is unlikely to be cured with currently available treatments
  • People whose AML has not gone into full remission (meaning the cancer has not fully responded to treatment), or whose disease has come back after treatment, including cases that never responded to treatment in the first place
  • People whose AML has come back after a bone marrow/stem cell transplant — including cases where the cancer has not visibly returned but is still detectable through lab tests (confirm with trial site)
  • People who have relapsed after a transplant and have been off immune-suppressing medications for at least one month before enrolling
  • People who have a suitable stem cell donor available
  • People whose kidneys, liver, and heart are functioning well enough to meet the trial's requirements (the trial site will assess this with specific tests)
  • People whose heart is pumping at 40% efficiency or better, confirmed by a heart scan
  • People whose lungs are functioning at more than 45% of the expected level
  • People who are generally well enough to carry out daily activities with no more than mild limitations (assessed using a standard scale called the ECOG scale, scores 0–1)
  • People who are willing to use acceptable birth control methods if there is any chance of pregnancy

Who may not be able to join:

  • People who are pregnant or currently breastfeeding
  • People with an active hepatitis B, hepatitis C, or HIV infection
  • People currently taking systemic (whole-body) steroids or other immune-suppressing medications
  • People with any serious uncontrolled medical condition that would make participation unsafe
  • People showing signs or symptoms that suggest the cancer may have spread to the brain or spinal cord
  • People with a known allergy or sensitivity to any of the substances used in the study product, specifically human serum albumin, DMSO, or Dextran 40
  • People with serious heart conditions classified as Class III or IV by standard heart disease guidelines
  • People who have had a clinically significant irregular heartbeat, or an irregular heartbeat that is not well-controlled with medication, within two weeks of the screening visit

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
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: Noelle Frey, MD, University of Pennsylvania

Phone: 215-349-8245

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
Registry
ClinicalTrials.gov
Start date
23 February 2024
Est. completion
23 February 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Manufacturing feasibility; Occurrence of dose-limiting toxicities related to CD33KO-HSPC; Occurrence of dose-limiting toxicities related to CART-33

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