Selective depletion of recipient-alloreactive T-cells while retaining viral-specific and memory T-cells enables safe and efficacious haplo-identical HSCT

      Haplo-identical HSCT may resolve the lack of sufficient suitable completely HLA-matched donors for treatment of end-stage blood-cancer patients with a HSCT. Yet, current techniques do not allow for such procedure as presence of T-cells will cause severe GvHD and absence of T-cells (i.e. naked HSCT) will lead to occurrence of opportunistic infections. Kiadis Pharma is developing ATIR, a T-cell immunotherapy based on a donor lymphocyte preparation selectively depleted of host alloreactive T-cells, through use of photo-dynamic therapy. In a dose-finding phase I/II clinical study (CR-GVH-001), the product was shown to enable safe and efficacious haplo-identical HSCT. Currently, a subsequent phase II clinical study (CR-AIR-007) is ongoing. Using recently developed analytical methods, the ATIR product from both studies was/is extensively characterized showing that only recipient-alloreactive T-cells were selectively depleted from the product while retaining reactivity against unrelated 3rd party antigens and general potent T-cells. Additionally, ATIR was shown to have retained viral-specific T-cells, preserved the presence of memory and naïve T-cells and showed responsiveness to pathogens. Thereby, ATIR will provide mature immune cells that offer immune protection without eliciting severe GvHD. The in vitro characterization data are supported by clinical data showing absence of TRM during 5-year follow-up (CR-GVH-001) over a broad dose range and no occurrence of severe GvHD/infections in the ongoing clinical study (CR-AIR-007). Together, these data show that using ATIR as an adjunctive medication, haplo-identical HSCT can be safe and efficacious.
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