Table 4.
Cell type | Organ K (kidney); L (liver) |
Type of trial |
Target dose (range) |
Trial ID |
---|---|---|---|---|
Regulatory DC | ||||
Autologous, blood monocyte-derived DCreg | K | Phase I/II | 106/kg | Nantes (ONE STUDY) NCT02252055 |
Donor blood monocyte-derived DCreg | K | Phase I | 0.5-5×106/kg (dose escalation) |
Pittsburgh NCT03164265 |
Donor blood monocyte-derived DCreg | L | Phase I/II | 2.5-10×106/kg | Pittsburgh NCT03726307 |
*Regulatory macrophages (Mreg) | ||||
Donor blood monocyte-derived Mreg | K | Phase I/II | 2.5-7.5×106/kg | Regensburgh (ONE STUDY) NCT 02085629 |
Regulatory T cells | ||||
Autologous, polyclonally-expanded Treg | K, L | Phase I/II | 0.5-10×106/kg | Charite (Germany) (ONE STUDY) ” NCT02371434 (K); KCL-Oxford (ONE STUDY) NCT02129881 (K); KCL NCT02166177 (L) |
Autologous, polyclonal or donor Ag alloreactive Treg | K | Phase I/II | 400±100×106 (TOTAL) |
UCSF NCT02711826 |
Autologous, donor Ag-alloreactive Treg | K, L | Phase I | 50-900×106 (TOTAL) |
UCSF (ONE STUDY) NCT02244801 (K); UCSF NCT02188719 (L); UCSF NCT02474199(L) |
Autologous, donor alloreactive ‘Tregenriched’ (co-cultured with CoSB) | K, L | Phase I | N/A (K); 0.23-6.37×106/kg (L) | MGH NCT02091232 (ONE STUDY) (K); JAPAN UMIN-000015789 (L) |
KCL, King’s College, London; MGH, Massachusetts General Hospital; UCSF, University of California San Francisco
For a more complete listing of Treg trials, in organ and bone marrow transplantation, see Kawai et al Human Immunology 2018 [90]