NCT06420063 Sequential CAR-T Cells Targeting CD33/CD123 in Patients With Acute Myelocytic Leukemia AML
| NCT ID | NCT06420063 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Essen Biotech |
| Condition | AML |
| Study Type | INTERVENTIONAL |
| Enrollment | 85 participants |
| Start Date | 2024-07-10 |
| Primary Completion | 2025-12-10 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
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 inf