Phase 2 Leukaemia Trial, Recruiting NCT06118788 Sponsor: Guangzhou Bio-gene Technology Co., Ltd Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT06118788
Recruiting Phase 2

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 are willing to give their consent to take part and are expected to complete all required visits and procedures.
  • Adults aged 18 to 70 years old (inclusive), of any gender.
  • People who have been diagnosed with acute myeloid leukaemia (AML) — a type of blood cancer — that has come back after treatment or has not responded to standard treatment, based on specific medical guidelines.
  • People whose leukaemia cells have tested positive for a specific protein marker called CLL-1 on at least 50% of the abnormal cells, confirmed by a laboratory test.
  • People who have mostly recovered from side effects of previous treatments, with only mild issues remaining (confirm with trial site).
  • People who are generally well enough to carry out everyday activities (rated 0 or 1 on a standard medical scale) and whose life expectancy is more than 3 months.
  • People whose liver, kidneys, heart, and blood are functioning within specific acceptable ranges as measured by blood tests and heart scans (confirm with trial site for exact values).
  • Women who are not able to become pregnant — for example, due to surgical removal of the uterus or ovaries, having had their tubes tied, or having gone through menopause for at least 1 year.
  • Women who could become pregnant but have a negative pregnancy test at the start of the trial and agree to use an approved contraceptive method throughout the trial and for 1 year after the last treatment.
  • Men who could father a child and agree to use barrier contraception or abstain from sex until 1 year after the last treatment.

Who may not be able to join:

  • People who have been diagnosed with a specific subtype of leukaemia called acute promyelocytic leukaemia.
  • People who have had another type of cancer within the past 3 years, with some exceptions for certain treated skin, cervical, thyroid, prostate, or breast cancers (confirm with trial site).
  • People who have signs that the leukaemia has spread to the brain or nervous system.
  • People who test positive for certain infections, including hepatitis B (with active virus detected), hepatitis C, HIV, cytomegalovirus (CMV), Epstein-Barr virus (EBV), or syphilis.
  • People who have a history of serious allergic reactions, or who are known to be allergic to any ingredients in the trial treatments, including products derived from mice or foreign proteins.
  • People with serious heart conditions, such as severe irregular heartbeat, unstable chest pain, a recent large heart attack, severe heart failure, or uncontrolled high blood pressure.
  • People who have previously had an organ transplant or are being planned for one (bone marrow/stem cell transplants are excluded from this rule).
  • People who currently have or have had graft-versus-host disease (a condition that can occur after a stem cell transplant where donor cells attack the body).
  • People who have had a stem cell transplant within the 6 months before joining the trial.
  • People with active autoimmune or inflammatory diseases affecting the nervous system, or active serious brain conditions (confirm with trial site for examples).
  • People who have a cancer-related emergency — such as a blockage, severe infection-related complications, or other urgent conditions — that needs immediate treatment before the trial can begin.
  • People who have an active infection that is not controlled and is being treated with antibiotics or antifungal/antiviral medicines.
  • People who have had major surgery within 4 weeks before starting the trial's preparation treatment, or whose surgical wounds have not yet fully healed.
  • People with a severe mental illness.
  • People who have recently received certain blood-stimulating medications (such as G-CSF or GM-CSF) within 1–2 weeks before the blood collection step of the trial, as these may affect how the treatment is prepared.
  • People who have been taking steroid tablets or immunosuppressant medicines within 2 weeks before the blood collection step (inhaled or skin-applied steroids may be acceptable — confirm with trial site).
  • People who have received a live or weakened-virus vaccine within 4 weeks before the trial screening visit.
  • People with alcohol dependency or a history of substance misuse.
  • People who have taken part in another clinical trial within the past 3 months.
  • People who have previously received any CAR-T cell therapy or other cell-based therapy.
  • People who, in the treating doctor's judgement, have any other medical condition that would make participation unsafe.

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 14 July 2026
Phase 2: approximately ~30% 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, Zhejiang University

Phone: +86 020 32030437

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 2
Sponsor
Guangzhou Bio-gene Technology Co., Ltd
Registry
ClinicalTrials.gov
Start date
7 March 2024
Est. completion
1 March 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Dose Limited Toxicity Rate; Incidence of Treatment-Emergent Adverse Events

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: 14 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