IS-free Treg Stem Cell Transplant

A Pilot/Phase 1 Study of Immunosuppression-free Regulatory T-cell Graft-engineered Haploidentical Hematopoietic Cell Transplantation in Relapsed/Refractory AML/MDS

What's the purpose of the trial?

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 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
Trial status

Accepting patients

Phase
Phase 1
Enrollment
30
Last Updated

Participating Centers

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Experimental Treatments

Learn more about the experimental treatments being evaluated in this clinical trial.

  • Melphalan is a chemotherapy medication used in the treatment of different cancers.
  • Donor Lymphocyte Infusion (DLI) is an infusion of lymphocytes (usually T cells) that come from a donor.
  • Thiotepa is an antineoplastic chemotherapy agent that is used to treat several different kinds of cancer.
  • Fludarabine is a chemotherapy medication that may be used in the treatment of many different cancers.
  • Total Body Irradiation is radiation therapy that is given to your entire body.
  • Cyclophosphamide is a chemotherapy agent used in the treatment of cancer.
  • Mesna is a cytoprotectant drug used to reduce the risk of bleeding from the bladder in patients receiving certain types of chemotherapy.

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