Sequential CAR-T Cells Targeting CD33/CD123 in Patients With Acute Myelocytic Leukemia AML
Recruiting now · Phase 1/Phase 2
Conditions studied: AML, Acute Myeloid Leukemia, AML, Adult Recurrent, AML, Adult
In brief
This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting CD33 or CD123 or both sequentially in the treatment of Acute Myelocytic Leukemia.
Key facts
- Study ID
- NCT06420063
- Run by
- Essen Biotech
- People needed
- 85
- Starts
- 2024-07-10
- Expected to finish
- 2026-12-28
- Last updated by the study team
- 2024-11-12
Who can join
Age: 6 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- District One Hospital — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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