Clinical trial · Interventional
NK Cell Infusion for Patients With Acute Myeloid Leukemia
Clinical Study of Natural Killer Cell Infusion in Patients With Acute Myeloid Leukemia
NCT04221971CI-TRIAL-00047436unknownPhase 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)
Natural killer (NK) cells exert antitumor effects via their cytotoxic and cytokine-secreting capacity without present of clinical symptoms. In recent years, with the continuous advancement of in vitro expansion methods, the application of good quality management technology, NK cells could be clinical grade expanded without the need for pre-purification, feeder-free, and serum-free culture. In this clinical trial the investigators want to demonstrate the safety and efficacy chemotherapy combined with donor-derived in vitro activated NK cells infusion for high risk AML patients.
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 |
|---|---|---|---|
| chemotherapy combined with NK cells infusion | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AML patients with NK cells infusion
- description
- The relapsed/refractory AML patient received Flu+CTX (Flu 25mg/m2 (-6d to -2d)，CTX 1.0g/m2 (-6d to -5d) and haploidentical NK cells infusion postchemotherapy for at least 48 hours. NK cell dose was over 1+E07/ kg with 3 consecutive infusions. NK cells infusion interval was 1 day.
- interventionNames
- Drug: chemotherapy combined with NK cells infusion
Primary outcomes (1)
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- timeFrame
- Two months after NK treatment
- description
- Closely monitor the patient's temperature, rash, BP, and other adverse reactions during the 48 hours after the infusion, and pay attention to acute and chronic GVHD; follow up once every 1-2 weeks within 6 months after the infusion, and review the blood count and biochemistry. Increase or decrease the relevant inspections and inspection frequencies as appropriate according to the condition;
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. AML patients receiving standard NCCN induction and consolidation chemotherapy; 2. Age\> = 18 years old; 3. Relapsed and refractory AML: continued non-remission after induction and consolidation chemotherapy with NCCN standard protocol, or relapse after remission, or continued MRD positive; 4. MDS-RAEB, MDS-AML, MPD-AML; 5. ECOG≤3; 6. No serious organ dysfunction within 2 weeks before treatment: 1. Heart: no arrhythmia and LVEF≥50% and no pericardial effusion; 2. Liver: liver function \<2 times the upper limit of ALT and \<1.5 times the upper limit of total bilirubin, no active hepatitis; 3. Kidney: serum creatinine \<1.5 mg / dl; or if serum creatinine exceeds the upper limit, serum creatinine clearance should be CrCl\> 50 ml / min; 4. indoor fingertip blood oxygen saturation ≧ 92%; 7. Expected survival time ≥ 3 months; 8. The interval between re-induction therapy and NK cell therapy is at least 2 weeks, and the toxic and side effects of all induction remission treatments have disappeared; if the patient is receiving non-invasive chemotherapy, such as hydroxyurea, low-dose cytarabine, before receiving this program Should be discontinued before; 9. All patients and donors are willing to join this clinical trial and sign informed consent. Exclusion Criteria: 1. Combined with a history of other malignant tumors \<5 years (except cured skin basal cell carcinoma, cured cervical carcinoma in situ and gastrointestinal tumors confirmed to be cured by endoscopic mucosal resection); 2. Have received bone marrow or organ transplant; 3. Those who are allergic to the biological agents used in this treatment; 4. active infection; 5. Those who received other cell treatments such as DLI, CMV-CTL, EBV-CTL; 6. HBV carriers; 7. Patients with extramedullary recurrence; 8. Chest radiographic examination to determine patients with pulmonary inflammation; 9. Researchers do not consider it appropriate to participate in this trial.
References
Publications (0)
Data not yet available
No reference posted for this study.