Clinical trial · Interventional
CAR-pNK Cell Immunotherapy for Relapsed/Refractory CD33+ AML
Clinical Investigation of Chimeric CD(Cluster of Differentiation)33 Antigen Receptor-modified NK92 Cells in Relapsed and/or Refractory Acute Myeloid Leukemias
NCT02944162CI-TRIAL-00025013unknownPhase 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)
The purpose of this clinical trial is to study genetically engineered NK92 cell therapy in treating patients with CD33 positive acute myeloid leukemias that is relapsed (after stem cell transplantation or intensive chemotherapy) or refractory to further chemotherapy.
Conditions
Conditions (5)
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 Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Acute Myeloid Leukemia With Maturation | Acute Myeloid Leukemia with Maturation | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia Without Maturation | Acute Myeloid Leukemia without Maturation | ONTOLOGY_EXACT | 0.98 |
| ANLL | Acute Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-CD33 CAR-NK cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR-NK Cell immunotherapy
- description
- Enrolled patients will receive CAR-NK cells immunotherapy with a novel specific chimeric antigen receptor targeting CD33 antigen by infusion.
- interventionNames
- Biological: anti-CD33 CAR-NK cells
Primary outcomes (1)
- measure
- Adverse events attributed to the administration of the anti-CD33 CAR-NK cells
- timeFrame
- One year
- description
- Defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events that are possibly, likely, or definitely related to study treatment
Secondary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male and female subjects with CD33+ acute myeloid leukemia in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (\>12 weeks to \< 2 year survival) with currently available therapies will be enrolled. 2. CD33+ acute myeloid leukemia CR (complete remission) can not be achieved after at least 2 prior combination chemotherapy regimens. 3. AML in CR2 or CR3 and not eligible for allogeneic SCT because of age, comorbid disease, or lack of available family member or unrelated donor. 4. Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \< 1 year). 5. Relapsed after prior autologous or allogenic SCT. AML patients with relapsed or residual disease after at least 1 prior therapy and not eligible for allogeneic SCT. 6. Residual disease after primary therapy and not eligible for autologous SCT. 7. All of those patients must also meet the following criteria: Expected survival \> 12 weeks. Creatinine \< 2.5 mg/dl ALT(alanine aminotransferase)/AST (aspartate aminotransferase)\< 3x normal Bilirubin \< 2.0 mg/dl Any relapse after prior SCT will make patient eligible regardless of other prior therapy. Adequate venous access for apheresis, and no other contraindications for leukapheresis. Ability to give informed consent. Exclusion Criteria: 1. Pregnant or nursing women may not participate. 2. Active HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at the time of screening. 3. Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders. 4. History of severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, or aldesleukin. 5. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary. 6. The existence of unstable or active ulcers or gastrointestinal bleeding. 7. Patients need anticoagulant therapy (such as warfarin or heparin). 8. Patients need long-term antiplatelet therapy (aspirin at a dose \> 300mg/d; clopidogrel at a dose \> 75mg/d).
References
Publications (1)
- DERIVEDDel Zotto G, Marcenaro E, Vacca P, Sivori S, Pende D, Della Chiesa M, Moretta F, Ingegnere T, Mingari MC, Moretta A, Moretta L. Markers and function of human NK cells in normal and pathological conditions. Cytometry B Clin Cytom. 2017 Mar;92(2):100-114. doi: 10.1002/cyto.b.21508. Epub 2017 Feb 12. PMID 28054442