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ATIR101 administered after T-cell-depleted haploidentical HSCT reduces NRM and improves overall survival in acute leukemia.


ABSTRACT: Overcoming graft-versus-host disease (GvHD) without increasing relapse and severe infections is a major challenge after allogeneic hematopoietic stem-cell transplantation (HSCT). ATIR101 is a haploidentical, naïve cell-enriched T-cell product, depleted of recipient-alloreactive T cells to minimize the risk of GvHD and provide graft-versus-infection and -leukemia activity. Safety and efficacy of ATIR101 administered after T-cell-depleted haploidentical HSCT (TCD-haplo?+?ATIR101) without posttransplant immunosuppressors were evaluated in a Phase 2, multicenter study of 23 patients with acute leukemia and compared with an observational cohort undergoing TCD-haplo alone (n?=?35), matched unrelated donor (MUD; n?=?64), mismatched unrelated donor (MMUD; n?=?37), and umbilical cord blood (UCB; n?=?22) HSCT. The primary endpoint, 6-month non-relapse mortality (NRM), was 13% with TCD-haplo?+?ATIR101. One year post HSCT, TCD-haplo?+?ATIR101 resulted in lower NRM versus TCD-haplo alone (P?=?0.008). GvHD-free, relapse-free survival (GRFS) was higher with TCD-haplo?+?ATIR101 versus MMUD and UCB (both P?

SUBMITTER: Roy DC 

PROVIDER: S-EPMC7326707 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Overcoming graft-versus-host disease (GvHD) without increasing relapse and severe infections is a major challenge after allogeneic hematopoietic stem-cell transplantation (HSCT). ATIR101 is a haploidentical, naïve cell-enriched T-cell product, depleted of recipient-alloreactive T cells to minimize the risk of GvHD and provide graft-versus-infection and -leukemia activity. Safety and efficacy of ATIR101 administered after T-cell-depleted haploidentical HSCT (TCD-haplo + ATIR101) without posttrans  ...[more]

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