期刊
BLOOD
卷 127, 期 8, 页码 1044-1051出版社
AMER SOC HEMATOLOGY
DOI: 10.1182/blood-2015-06-653667
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资金
- National Institutes of Health (NIH) National Cancer Institute [P30 CA77598, P01 CA65493, R01 CA105216]
- Leukemia and Lymphoma Society Scholar in Clinical Research Award grant [CDP-2417-11]
- Children's Cancer Research Fund
- NIH National Heart, Lung, and Blood Institute [R01 HL11879, HHSN268201000008C]
- Leukemia and Lymphoma Translational Research grant [R6029-07]
We studied the safety and clinical outcomes of patients treated with umbilical cord blood (UCB)-derived regulatory T cells (Tregs) that expanded in cultures stimulated with K562 cells modified to express the high-affinity Fc receptor (CD64) and CD86, the natural ligand of CD28 (KT64/86). Eleven patients were treated with Treg doses from 3-100x10(6) Treg/kg. The median proportion of CD4(+)FoxP3(+)CD127(-) in the infused product was 87% (range, 78%-95%), and we observed no dose-limiting infusional adverse events. Clinical outcomes were compared with contemporary controls (n = 22) who received the same conditioning regimen with sirolimus and mycophenolate mofetil immune suppression. The incidence of grade II-IV acute graft-versus-host disease (GVHD) at 100 days was 9% (95% confidence interval [CI], 0-25) vs 45% (95% CI, 24-67) in controls (P=.05). Chronic GVHD at 1 year was zero in Tregs and 14% in controls. Hematopoietic recovery and chimerism, cumulative density of infections, nonrelapse mortality, relapse, and disease-free survival were similar in the Treg recipients and controls. KT64/86-expanded UCB Tregs were safe and resulted in low risk of acute GVHD.
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