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Severe (3-4) acute graft anti-host disease (AGVHD) is the main cause of death after patient non-kinship (URD) hematoblast transplantation, especially the higher mortality rate after HLA disassocation transplantation.
currently approved AGVHD preventive drugs, highlighting the urgent need for new treatments.
ABA2 is a Phase II trial designed to rigorously assess the safety, effectiveness, and immunological effects of T-cell costulent blocking containing abatacept in the prevention of transplant anti-host disease (GVHD) based on calcium-adjusted neurophosphatase inhibitors (CNI)/methotrexate (MTX) to test whether Abasep can reduce the risk of AGVHD.
the study process recruited adults and children with malignant blood disease and divided into two queues: 1) random double-blind placebo-controlled queues (8/8-HLA-matched URD), compared to CNI/MTX-Absap vs. CNI/MTX plus placebo; 2) One-arm queue (7/8-HLA-mismatched URD), compared to CNI/MTX-Absap vs. CNI/MTX CIBMTR.
3-4 AGVHD after 100 days and the secondary end point is non-severe AGVHD survival rate (SGFS) after 180 days.
8/8 and 7/8 queues of 3-4 AGVHD in both queues recruited 142 transplant recipients (716 days of medium follow-up) and 43 transplant recipients (708 days) respectively.
in the 8/8 queue, the rates of 3-4 AGVHD were 6.8% (Absap group) and 6.8% (placebo group) (p-0.13, hazardous) The non-severe AGVHD survival rate (SGFS) was 93.2% (Absap group) and 82% (placebo group, p-0.05), respectively.
the probability of two-queue SGFS in a smaller 7/8 queue, the 3-4 AGVHD probability of CNI/MTX combined with Absap group was 2.3%, significantly better than the non-random match of CNI/MTX Queues (30.2%, p.lt;0.001), and the advantages of SGFS are even more pronounced (97.7% vs. 58.7%, p.lt;0.001).
immunological analysis showed that T-cell activity was controlled in patients treated with absip.
, it is safe to add Abaaoud in the URD HCT process, which can reduce the occurrence of AGVHD and improve SGFS.
results show that Abrasip can significantly improve the prognostication of AGVHD-related transplantation, especially for HLA-related HCT effects.
