Clinical trial · Interventional
Natural Killer Cells Infusion for Treating Acute Myeloid Leukemia Patients With Minimal Residual Disease
Phase I Clinical Trial of Haploid Donor-derived in Vitro Activated Natural Killer Cells Infusion for Patients With Minimal Residual Disease After Consolidation Therapy for Acute Myeloid Leukemia
NCT04209712CI-TRIAL-00046274unknownEarly Phase 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 trial will evaluate the effectiveness and safety of haploid donor-derived in vitro activated natural killer(NK) cells infusion for Treating acute myeloid leukemia Patients With minimal residual disease.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| haploid allogeneic NK cell therapy | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- haploid allogeneic NK cell therapy
- description
- haploid allogeneic NK cell therapy with chemotherapy
- interventionNames
- Biological: haploid allogeneic NK cell therapy
Primary outcomes (1)
- measure
- Minimal Residual Disease (MRD)
- timeFrame
- 12 months
- description
- MRD-negative is defined as \<0.1% blasts with leukemia-associated phenotype detected by flow cytometry. MRD-positive is defined as \>=0.1% blasts with leukemia-associated phenotype detected by flow cytometry.
Secondary outcomes (1)
- measure
- Number of participants with adverse events
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients diagnosed with acute myeloid leukemia; 2. MRD after 2 course of standard chemotherapy; 3. No plan for hematopoietic stem cell transplantation; 4. Hemoglobin (Hb) \>=60g/L, white blood cell count (WBC) \>=2.5x10\^9/L, platelet count \>=30x10\^9/L; 5. Patients have self-knowledge ability and can sign informed and voluntary consent forms; 6. Patients or their clients, guardians of pediatric patients signed the informed and voluntary consent form and joined the study. Exclusion Criteria: 1. Intracranial hypertension or unconsciousness; 2. Symptomatic heart failure or severe arrhythmia; 3. Respiratory failure; 4. With other types of malignant tumor diseases; 5. T lymphocytic acute leukemia; 6. Diffuse intravascular; 7. Serum creatinine and / or urea nitrogen \>=1.5 times the normal value;coagulation; 8. Serum total bilirubin \>=1.5 times the normal value; 9. Sepsis or other difficult-to-control infections; 10. Uncontrollable diabetes; 11. severe mental disorders; 12. WHO physical status classification \>=3; 13. People who are allergic to Interleukin-2; 14. Patients after organ transplant; 15. Pregnant and lactating women.
References
Publications (0)
Data not yet available
No reference posted for this study.