Clinical trial · Interventional
CD123-Targeted CAR-T Cell Therapy for Relapsed/Refractory Acute Myeloid Leukemia
NCT04265963CI-TRIAL-00065760unknownPhase 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)
There are limited options for treatment of relapse/refractory acute myeloid leukemia (AML). CD123 CAR-T cells may have an attractive and permanent effect on anti-tumor. This study purpose to estimate the safety and efficiency of CD123 CAR-T cells to patients with relapse/refractory AML.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Leukemia, Myeloid | Myeloid Leukemia | ALIAS | 0.90 |
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD123 CAR-T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD123 CAR-T cells treat
- description
- Patients will be be treated with CD123 CAR-T cells
- interventionNames
- Biological: CD123 CAR-T cells
Primary outcomes (2)
- measure
- Adverse events that related to treatment
- timeFrame
- 2 years
- description
- Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
- measure
- The response rate of CD123 CAR-T treatment in patients with relapse/refractory AML that treatment by CD123 CAR-T cells therapy
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed written informed consent; 2. Diagnose as Relapsed/Refractory AML, and meet one of the following conditions: 1. With persistent disease after at least two lines of therapy; 2. Relapse to the last line of therapy in 6 months,as known as early recurrence; 3. Relapse to the last line of therapy after 6 months, but refractory to this last line of therapy; 4. Relapse more than once. The definition of relapse: Reappearance of blasts in the blood or bone marrow (\>5%) or in any extramedullary site after a CR (the most common are CNS and testicular leukemia). 3. Evidence for cell membrane CD123 expression; 4. KPS\>60; 5. The expect time of survive is above 3 months; 6. Ages: 2 to 75 years; 7. All genders; 8. The patients that diagnosis as high risks, relapse/refractory or inconformity criteria to other therapy; 9. No serious mental disorders; 10. Left ventricular ejection fraction ≥40%; 11. Sufficient hepatic function defined by ALT/AST\<5 x ULN and bilirubin≤34.2μmol/L; 12. Sufficient renal function defined by creatinine clearance \<220μmol/L; 13. Sufficient pulmonary function defined by indoor oxygen saturation≥92%; 14. No other illness may conflict with the protocol (e.g. autoimmune diseases, immune deficiency and organ transplantation; 15. Ability and willingness to adhere to the study visit schedule and all protocol requirements. Exclusion Criteria: 1. Previous history of other malignancy; 2. Presence of uncontrolled active infection; 3. Evidence of disorder that need the treatment by glucocorticoids; 4. Active or chronic GVHD; 5. The patients treatment by inhibitor of T cell; 6. Pregnant or breasting-feeding women; 7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.
References
Publications (0)
Data not yet available
No reference posted for this study.