Eight-Treg study: a phase I dose escalation trial of adoptive immunotherapy with autologous ex vivo expanded regulatory CD8+ T cells in living donor kidney transplant recipients

chronic renal failure requiring kidney transplantation

Occurrence of a dose-limiting toxicity up to visit 10, at 3 months post-graft. A Dose-Limiting Toxicity (DLT) is defined as a clinically significant AE or abnormal laboratory value:  Unrelated to the kidney transplant, intercurrent illness, or concomitant medications  Grade 3, 4 or 5 non-hematologic toxicity (with exceptions)

Occurrence of a DLT up to 6- and 12-months post-graft, and anatomopathological and im-munohistological (HD) analysis of the graft biopsies at 1- and 3-months post-graft., Incidence, duration and severity of infections, and total immunosuppressive burden at one-year post-graft., 3 Real time follow-up of blood cell count, analysis of the DSA and of cytokines in plasma and urine; kinetic of absolute count of blood cells and high density spectral immunophenotyping at protein and transcriptional levels of PBMC; tracking the infused cells in blood; identifying Tregs clones emerging; evaluating the suppressive capacity of circulating Tregs; evaluating the reac-tivity of circulating T cells ; immunohistochemical staining and spatial transcriptomic of graft biopsies, 4 Comparison of blood Tregs profile, emerging clones, and donor reactive T cells; and perturba-tion of graft infiltrate after cell therapy compared to standard treatment from a control biocollec-tion (DIVAT declared on 09/05/2011 under the n°DC-2011-1399) and historical databases.

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