Phase 1 Leukaemia Trial, Recruiting NCT05043571 Sponsor: National University Hospital, Singapore Condition: Leukaemia
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Phase 1 Leukaemia Trial, Recruiting

NCT05043571
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 who have been diagnosed with T-cell acute lymphoblastic leukaemia or lymphoma that has come back after treatment (relapsed), where disease is detected in the bone marrow, the fluid around the brain and spinal cord, the eye, brain, testes, or other areas of the body.
  • People whose leukaemia did not respond well enough to initial (induction) treatment, based on the level of remaining cancer cells detected by laboratory tests or the proportion of abnormal cells still found in the bone marrow.
  • People whose disease has remained detectable at two or more check points after initial treatment, based on laboratory testing of cancer cell levels.
  • People with only mild or no breathing difficulties and an oxygen level above 95% while breathing normal room air.
  • People whose heart pumping function meets minimum levels, confirmed by a heart ultrasound (echocardiogram) taken within the past 3 months.
  • People with a performance status score of 50 or above on the relevant scale for their age (Karnofsky scale for those aged 16 and over; Lansky scale for those under 16), assessed at the time of screening.
  • People with normal kidney function for their age, confirmed within the past 3 months.
  • People with liver enzyme (ALT) levels no higher than five times the upper normal limit for their age.
  • People whose cancer cells show more than 99% expression of a marker called CD7 on the surface of the abnormal cells, making them eligible for the specific CAR-T cell treatment used in this trial.

Who may not be able to join:

  • People who do not meet the inclusion criteria listed above.
  • People who are pregnant or breastfeeding, or who return a positive pregnancy test.
  • People with certain inherited conditions linked to bone marrow failure, such as Fanconi anaemia, Kostmann syndrome, or Shwachman syndrome, or other similar conditions — with the exception of Down syndrome.
  • People with a history of another cancer, unless it was a very early-stage skin or cervical cancer that was fully treated with no signs of the disease remaining.
  • People with an active or recent hepatitis B or hepatitis C infection within 8 weeks before screening, or any other infection that is not currently under control.
  • People who tested positive for HIV within 8 weeks before screening.
  • People experiencing moderate to severe acute graft-versus-host disease (a complication that can occur after bone marrow or stem cell transplant) or extensive chronic graft-versus-host disease.
  • People who have received another experimental or investigational treatment within 30 days before screening.
  • People with certain brain or nervous system complications, including uncontrolled seizures, increased pressure inside the skull, or a reduced level of consciousness from any cause.

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 23 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: Allen Yeoh, M.D, National University Hospital, Singapore

Phone: +65 6772 2002

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
National University Hospital, Singapore
Registry
ClinicalTrials.gov
Start date
8 September 2021
Est. completion
1 November 2026

Where this trial is recruiting

🇸🇬 Singapore

Primary endpoints

Proportion of participant who are flow cytometry minimal residual disease (MRD) negativity at 1 month after Anti-CD7 PEBL CAR T-cell infusion.

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: 23 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