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Phase I Study of Ex Vivo Expanded/Activated Gamma Delta T-cell Infusion Following Haploidentical Hematopoietic Stem Cell Transplantation and Post-transplant Cyclophosphamide

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Trial Profile

Phase I Study of Ex Vivo Expanded/Activated Gamma Delta T-cell Infusion Following Haploidentical Hematopoietic Stem Cell Transplantation and Post-transplant Cyclophosphamide

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 19 Mar 2025

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At a glance

  • Drugs INB-100 (Primary) ; Cyclophosphamide; Fludarabine
  • Indications Acute myeloid leukaemia; Chronic myeloid leukaemia; Haematological malignancies; Myelodysplastic syndromes; Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; First in man

Most Recent Events

  • 13 Mar 2025 According to an IN8bio media release, guidance from the U.S. Food and Drug Administration (FDA) confirmed relapse-free survival (RFS) in AML patients as an acceptable primary endpoint for a potential pivotal randomized control trial. Company expect to present updated clinical data in the second half of 2025.
  • 13 Mar 2025 According to an IN8bio media release, company is accelerating patient enrollment in expansion cohort of ongoing Phase 1 clinical trial including the inclusion of an additional investigational center.
  • 14 Feb 2025 According to an IN8bio media release, data from this study was presented at the 2025 Transplantation & Cellular Therapy (TCT) Meetings in Hawaii.

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