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Summary  Graft‐versus‐host disease ( GVHD ) is a major cause of transplant‐related mortality ( TRM ) after allogeneic haematopoietic stem cell transplantation ( HSCT ) and presents a challenge in haploidentical  HSCT .  GVHD  may be prevented by  ex vivo  graft T‐cell depletion or  in vivo  depletion of proliferating lymphocytes. However, both approaches pose significant risks, particularly infections and relapse, compromising survival. A photodepletion strategy to eliminate alloreactive T cells from mismatched donor lymphocyte infusions (enabling administration without immunosuppression), was used to develop  ATIR 101, an adjunctive therapy for use after haploidentical  HSCT . In this phase I dose‐finding study, 19 adults (median age: 54 years) with high‐risk haematological malignancies were treated with T‐cell‐depleted human leucocyte antigen‐haploidentical myeloablative  HSCT  followed by  ATIR 101 at doses of 1 × 10 4 –5 × 10 6   CD 3 +  cells/kg (median 31 days post‐transplant). No patient received post‐transplant immunosuppression or developed grade  III / IV  acute  GVHD , demonstrating the feasibility of  ATIR 101 infusion for evaluation in two subsequent phase 2 studies. Additionally, we report long‐term follow ‐up of patients treated with  ATIR 101 in this study. At 1 year, all 9 patients receiving doses of 0·3–2 × 10 6   CD 3 +  cells/kg  ATIR 101 remained free of serious infections and after more than 8 years,  TRM  was 0%, relapse‐related mortality was 33% and overall survival was 67% in these patients.

british journal of haematology

Allodepleted T‐cell immunotherapy after haploidentical haematopoietic stem cell transplantation without severe acute graft‐versus‐host disease ( GVHD ) in the absence of  GVHD  prophylaxis