Clinical trial · Interventional
Haploidentical NK Cell Infusion in Malignant Melanoma
Phase I/II Study of Haploidentical Natural Killer Cell Infusion in Patients With Refractory or Relapsed Malignant Melanoma
NCT00846833CI-TRIAL-00007127completedPhase 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)
We hypothesized that haploidentical NK cells kill tumor cells more efficiently than autologous NK cells, based on the missing-self hypothesis. Therefore, we performed this study to investigate the role of haploidentical NK cell therapy in patients with refractory or relapsed malignant melanoma.
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 |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Haploidentical NK cell | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cyclophosphamide, high-dose interleukin-2, NK cell
- interventionNames
- Biological: Haploidentical NK cell
Primary outcomes (1)
- measure
- To determine the maximum-tolerated dose of haploidentical NK cells
- timeFrame
- 1 year
Secondary outcomes (3)
- measure
- To assess NK cell infusion-related toxicity
- timeFrame
- 2 years
- measure
- To evaluate response rate
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed metastatic or relapsed malignant melanoma * Patients who received prior chemotherapy or immunotherapy * Patients who have at least one haploidentical donor willing to donate * ECOG performance status 0 or 1 * 18 - 75 years * At least one measurable disease according to the RECIST criteria * Patients with 45% or more left ventricular ejection fraction * Patients with 50% or more predicted DLCO * Adequate bone marrow function: absolute neutrophil count ≥ 1.5 x 109/L; platelet count ≥ 100 x 109/L; and hemoglobin ≥ 9 g/dL * Adequate liver function: total bilirubin ≤ 1.0 x upper limit of the normal range (ULN); AST/ALT ≤ 2.5 x ULN; and alkaline phosphatase ≤ 2.5 x ULN * Adequate renal function: serum creatinine ≤ 1.0 x ULN or creatinine clearance ≥ 60 mL/min/1.73m2 * At least 3 months of expected survival * Patients who signed informed consent Exclusion Criteria: * Patients who received other chemotherapeutic agents within 30 days prior to study enrollment * Patients who received adoptive cell therapy including hematopoietic stem cell transplantation * Patients infected with HIV, HBV, or HCV * Hypersensitivity to cyclophosphamide or interleukin-2 * Patients who received organ transplantation * Patients who had arrhythmia or ischemic heart disease * Pregnant or lactating women * Patients with uncontrolled infection who did not respond to appropriate antimicrobial agents
References
Publications (0)
Data not yet available
No reference posted for this study.