Haploidentical Stem Cell Transplantation and NK Cell Therapy in Patients With High-risk Solid Tumors
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About
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.
Full 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.
Enrollment
Sex
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Volunteers
Inclusion criteria
- age < 21 years old
- Patients with high-risk solid tumors who failed prior HDCT/autoSCT
- Patients with a suitable haploidentical donor
- High-risk solid tumors include high-risk neuroblastoma, metastatic or relapsed Ewing sarcoma, relapsed osteosarcoma, high-risk brain tumors, relapsed germ cell tumors, relapsed soft tissue sarcoma, relapsed rhabdomyosarcoma, and etc.
- stable disease with salvage chemotherapy after relapse
Exclusion criteria
- organ dysfunction(NCI common toxicity criteria grade > 2)
- progression of disease despite salvage chemotherapy
Trial design
Primary purpose
Allocation
Interventional model
Masking
12 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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