NCT01807468

Haploidentical Stem Cell Transplantation and NK Cell Therapy in Patients With High-risk Solid Tumors

Haploidentical Stem Cell Transplantation Followed by NK Cell Infusion in Patients With High-risk Solid Tumors Who Failed Autologous Stem Cell Transplantation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

To evaluate feasibility and efficacy of haploidentical stem cell transplantation in patients with high-risk solid tumors who failed after tandem high-dose chemotherapy and autologous stem cell transplantation. To evaluate feasibility and efficacy of NK cell infusion after haploidentical stem cell transplantation in patients with high-risk solid tumors who failed after tandem high-dose chemotherapy and autologous stem cell transplantation.

Detailed description

HaploSCT following reduced-intensity conditioning (RIC) regimen will be performed in patients with high-risk solid tumors. Both parents will be evaluated for their KIR genotype and phenotype and the one with the greatest degree of KIR-L mismatch with the patient will be selected as the donor. In addition, ex-vivo expanded NK cells derived from the donor will then be administered after haploSCT to increase the GVT effect. Low-dose IL-2 will be given after expanded NK cell infusion to enhance NK cell alloreactivity.

Conditions

• Neuroblastoma
• Ewing Sarcoma
• Rhabdomyosarcoma
• Osteosarcoma
• Soft Tissue Sarcoma

Interventions

Type	Name	Description
PROCEDURE	haploidentical stem cell transplantation and NK cell therapy

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-12-01
• Completion: 2019-06-01
• First posted: 2013-03-08
• Last updated: 2018-09-18

Locations

1 site across 1 country: South Korea