drugset
drugset / Trial / NCT04678401

IS-free Treg HaploHCT

NCT04678401 ↗

Phase 1 Recruiting 30 enrolled Dana-Farber Cancer Institute
Non-randomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start
2021-01-12
Primary completion
2028-08-31
Completion
2029-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Treg-enriched donor cell Cell therapy 1 cells/kg Intravenous
Subject Treg-enriched donor cell Cell therapy 2 cells/kg Intravenous
Subject Unmodified donor T Cell Cell therapy 0.5 cells/kg Intravenous
Subject Unmodified donor T Cell Cell therapy 1 cells/kg Intravenous
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule 3.75 mg/kg Intravenous
Background Cyclophosphamide Other / unclassified 15 mg/kg Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous
Background Fludarabine Small molecule 40 mg/m2 Intravenous
Background Melphalan Small molecule 100 mg/m2 Intravenous
Background Thiotepa Other / unclassified 3.75 mg/kg Intravenous
Background Thiotepa Other / unclassified 5 mg/kg Intravenous

Indications

acute myeloid leukemia graft versus host disease myelodysplastic syndrome