Clinical trial · Interventional
A Study of A-CAR028 Treatment in Subjects With Relapsed or Refractory Acute Myeloid Leukemia
A Study of A-CAR028 Treatment in Subjects With Relapsed/ Refractory Acute Myeloid Leukemia
NCT07198867CI-TRIAL-00096005recruitingPhase 1ClinicalTrials.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 a single-center, open-label study to evaluate the safety and efficacy of A-CAR028 in relapsed/refractory acute myeloid leukemia patients
Conditions
Conditions (2)
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 (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| CAR-T Cell Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| A-CAR028 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A-CAR028
- description
- Autologous A-CAR028 administered by intravenous (IV) infusion
- interventionNames
- Biological: A-CAR028
Primary outcomes (2)
- measure
- Incidence of dose limiting toxicities (DLTs)
- timeFrame
- Throughout the 28 days post A-CAR028 infusion
- measure
- Incidence and severity of Treatment Emergent Adverse Events (TEAEs)
- timeFrame
- Throughout the 3 months post A-CAR028 infusion
Secondary outcomes (10)
- measure
- Incidence and severity of Adverse Events (AEs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 18 to 75 years old at the time of signing the Informed Consent Form (ICF) * More than 12 weeks of expected survival * ECOG score 0 or 1 * Relapsed or refractory AML * Adequate organ function Exclusion Criteria: * Acute Promyelocytic Leukemia (APL) * Mixed Phenotype Acute Leukemia (MPAL) * Acute Undifferentiated Leukemia (AUL) * Only extramedullary leukemia * Known allergies to the components or excipients of the A-CAR028 cell product * Severe heart diseases, including but not limited to, myocardial infarction, angioplasty or stent implantation within 12 months prior to signing the ICF, unstable angina pectoris, severe arrhythmia, history of severe non-ischemic cardiomyopathy, heart failure * Autologous or allogeneic hematopoietic stem cell transplantation within 3 months prior to signing the ICF * Central nervous system (CNS) involvement or symptoms of CNS involvement (including cranial nerve lesions and extensive lesions or spinal cord compression) * A stroke or seizure occurred within 12 months prior to signing the ICF * Malignancy history within 5 years prior to signing the ICF * Uncontrolled active infection * Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive * Live vaccine injection within 4 weeks prior to signing the ICF * Acute or chronic graft-versus-host disease (GVHD) was present at screening * Inadequate washing time for previous treatment * Previously treated with CAR-T cell products or genetically modified T cell therapies
References
Publications (0)
Data not yet available
No reference posted for this study.