Clinical trial · Interventional
Sequential CAR-T Cells Targeting CD33/CD123 in Patients With Acute Myelocytic Leukemia AML
Sequential CAR-T Cell Infusion Targeting CD33 and CD123 for Refractory/Relapsed Acute Myeloid Leukaemia
NCT06420063CI-TRIAL-00082480BAH244recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| AML, Adult | Adult Acute Myeloid Leukemia | ALIAS | 0.90 |
| AML, Adult Recurrent | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD123/CD33 CART | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (CD33/CD123 CAR T cells, chemotherapy)
- description
- Patients will be administered fludarabine phosphate intravenously (IV) over a 30-minute period on days -4 to -2. Additionally, cyclophosphamide will be administered intravenously (IV) over 60 minutes on day -2. Subsequently, patients will receive CD33/123 CAR T cells intravenously (IV) over a duration of 10-20 minutes on day 0. Patients who exhibit positive responses to the initial dose of CD33/123 CAR T cells, do not experience unacceptable side effects, and have a sufficient quantity of cells available may be eligible to receive 2 or 3 additional doses of CD33/CD123 CAR T cells.
- interventionNames
- Biological: CD123/CD33 CART
Primary outcomes (1)
- measure
- Incidence and severity of dose-limiting toxicities (DLTs) following chemotherapy preparative regimen and infusion of CD5/CD7 chimeric antigen receptor (CAR) T cells
- timeFrame
- 28 days
- description
- Will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 at three dose levels until the maximum tolerated dose (MTD) is determined.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.