Myelodysplastic Syndromes Clinical Trial
Official title:
A Pilot/Phase 1 Study of Immunosuppression-free Regulatory T-cell Graft-engineered Haploidentical Hematopoietic Cell Transplantation in Relapsed/Refractory and Ultra-High-risk AML/MDS
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 study is assessing whether the IS-free Treg-cell graft-engineered haplo HSCT) approach will reduce risk of relapse while preventing usual toxicities related to stem cell transplants (e.g., graft-versus-host-disease (GVHD)). GVHD is a complication of transplantation where the T cells (a type of white blood cell that helps protect the body from relapse by killing cancer cells) in the donor graft attack and damage some of the host tissues. Patients who receive an allogeneic (using another person as the donor) hematopoietic stem cell transplant (HSCT) may develop graft-versus-host disease (GVHD) toxicity and are also at risk of disease relapse. The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits. Participants will receive the study intervention Treg-enriched donor cells and will then be followed for 1 year after transplantation. It is expected that about 20 people will take part in this research study. Dana-Farber Cancer Institute research funds along with charitable donations are supporting this research study. Regeneron Pharmaceuticals, Inc. (a pharmaceutical company) is also supporting this research study by providing funding and support for correlative laboratory tests. ;
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