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Study identifier: NCT04678401 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

IS-free Treg HaploHCT

Condition: Stem Cell Transplant Complications · Graft Vs Host Disease · Myeloid Leukemia, Acute  ·  Sponsor: Dana-Farber Cancer Institute

PhasePhase 1
Planned participants30
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

This research study is evaluating the safety and efficacy of the IS-free Treg-cell graft-engineered haplo transplant method in people with relapsed/refractory and Ultra-high risk acute myeloid leukemia (AML) and/or myelodysplastic syndromes (MDS) receiving a haploidentical donor allogeneic hematopoietic stem cell transplant (HSCT). The names of the study interventions involved in this study are: * Radiation-Total Myeloid and Lymphoid Irradiation (TMLI) * Chemotherapy (Fludarabine, Thiotepa, Cyclophosphamide plus Mesna) * Infusion of haplo Treg-enriched donor cells (experimental therapy) * Infusion of unmodified haplo donor T cells (includes cancer-fighting T effector cells) * Infusion of haplo donor CD34+ Peripheral Blood Stem Cells

This description comes directly from the study's public registry record.

Talk to the study team

John Koreth, MBBS, DPhil  ·  (617) 632-2949  ·  john_koreth@dfci.harvard.edu

Always discuss trial participation with your own doctor first.

Locations (1)

Dana Farber Cancer InstituteBoston, Massachusetts, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT04678401