CAR-T cell therapy targeting CD33 and CD123 for treating acute myeloid leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of chimeric antigen receptor T cell (CAR-T) immunotherapy targeting CD33 and CD123 in patients with acute myelocytic leukemia (AML). It is an open, single-arm study that aims to assess the feasibility of using CAR-T cells sequentially against these targets in patients who have relapsed or refractory AML. The primary focus is on monitoring adverse effects, including cytokine storm responses, and evaluating disease status post-treatment. The study also seeks to understand the persistence and function of CAR-T cells in the AML patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subjects with acute myeloid leukemia who voluntarily signed informed consent and met the following criteria:
* Age older than 6 months.
* Confirmed expression of CLL-1, CD123 and/or CD33 in blast AML by immuno-histochemical staining or flow cytometry.
* Karnofsky performance status (KPS) score is higher than 80 and life expectancy \> 3 months.
* Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg/dL.
* Hgb≥80g/L.
* No cell separation contraindications.
* Abilities to understand and the willingness to provide written informed consent.

Exclusion Criteria:

* Severe illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.
* Active bacterial, fungal or viral infection not controlled by adequate treatment.
* Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
* Pregnant or nursing women may not participate.
* Use of glucocorticoid for systemic therapy within one week prior to entering the trial.
* Patients, in the opinion of investigators, may not be able to comply with the study.

Where it's running

• District One Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Rhoda M Smith, Phd
• Email: clinical-trials@essen-biotech.com
• Phone: +12077706670

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.