Clinical trial · Interventional
Treatment of Relapsed or Refractory Neuroblastoma and Osteosarcoma With Expanded Haploidentical NK Cells and Hu14.18-IL2
Treatment of Relapsed or Refractory Neuroblastoma and Osteosarcoma With Ex-Vivo Expanded and Activated Haploidentical NK Cells and Hu14.18-IL2
NCT03209869CI-TRIAL-00060817withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): resources limited due to COVID-19
Summary
Brief summary (as posted)
Subjects with relapsed or refractory neuroblastoma and osteosarcoma will receive ex-vivo expanded and activated natural killer (NK) cells from a haploidentical donor in conjunction with the immunocytokine, hu14.18-IL2.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
| Recurrent Neuroblastoma | Neuroblastoma | CURATED_BROADER | 0.78 |
| Relapsed Neuroblastoma | Neuroblastoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ex vivo Expanded and Activated Haploidentical Donor NK Cells | Biological | — | UNRESOLVED |
| Hu14.18-IL2 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm
- description
- All subjects will receive Ex vivo Expanded and Activated Haploidentical Donor NK Cells + hu14.18-IL2
- interventionNames
- Biological: Ex vivo Expanded and Activated Haploidentical Donor NK Cells
- Biological: Hu14.18-IL2
Primary outcomes (2)
- measure
- Safety: Incidence of treatment-emergent adverse events of treatment with AENK cells and hu14.18-IL2
- timeFrame
- up to 28 days after final dose of EA-NK cells or hu14.18-IL2, whichever occurs last
- description
- Safety will be assessed by quantifying adverse events ≥ grade 3, using CTCAE (v.5), with certain pre-defined exceptions based on known, transient, reversible, clinically manageable toxicities of the chemotherapy and hu14.18-IL2.
- measure
- Safety: Incidence of any grade acute or chronic GVHD
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 7 Months
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * Relapsed or refractory neuroblastoma * Relapsed or refractory Osteosarcoma * Karnofsky/Lansky performance score \> 50 * Life expectancy ≥ 4 months * Creatinine clearance or radioisotope GFR ≥ 60 ml/min/1.73m2 OR serum creatinine within normal limits based on age and gender * ANC ≥ 750/µL * Platelet count ≥ 50,000/µL * Hemoglobin ≥ 8 g/dL * Total bilirubin ≤ 1.5 x upper limit of normal for age * ALT (SCPT) ≤ 5 x upper limit of normal for age * Shortening fraction of ≥ 27% by echocardiogram OR Ejection fraction of ≥55% by MUGA * No evidence of dyspnea at rest * Pulse oximetry \> 94% on room air * If PFTs performed, FEV1/FVC must be \> 60% * All Osteosarcoma patients must have PFTs performed * CNS toxicity ≤ Grade 2 * Patients with seizure disorders may be enrolled if seizures are well controlled on anticonvulsant therapy * \> 100 days after autologous stem cell infusion following myeloablative therapy * ≥ 2 weeks since chemotherapy * ≥ 7 days since anti-neoplastic, non-myelosuppressive biologic agent (or extended for agents known to have adverse events beyond the 7- day period) * ≥ 2 weeks for local palliative XRT * ≥ 6 months if prior craniospinal axis XRT (\> 50%) * ≥ 6 months if \> 50% radiation of pelvis * ≥ 6 weeks after therapeutic 131I-MIBG * ≥ 6 weeks since thoracotomy * Informed consent obtained (patient or legal representative) * Women of reproductive potential must have negative pregnancy test and be willing to use effective birth control method * Suitable haploidentical donor must be available Exclusion Criteria: * Prior history of ventilator support related to lung injury, except for immediately following thoracotomy * Symptomatic pleural effusions or ascites * \<6 weeks from thoracotomy and \<2 weeks from other major surgery * History of anaphylaxis while receiving prior anti-GD2 therapy * Pregnant * HIV infection * Heart failure or uncontrolled cardiac rhythm disturbance * Active infection * Prior organ allograft * Prior allogeneic bone marrow or peripheral blood stem cell transplant * Significant serious intercurrent illnesses expected to interfere with the antitumor effect of treatment or to significantly increase the severity of toxicities experienced from treatment * Any mental or physical condition, in the opinion of the PI (or PI designee), which could interfere with the ability of the subject (or the only parent or legal guardian available to care for the subject) to understand or adhere to the requirements of the study. * Enrollment in any other treatment study from screening up to 28 days after the last treatment on this study (unless PI judges such enrollment would not interfere with endpoints of this study)
References
Publications (0)
Data not yet available
No reference posted for this study.