IS-free Treg HaploHCT
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Graft Vs Host Disease
- Myelodysplastic Syndromes
- Myeloid Leukemia in Relapse (Disorder)
- Myeloid Leukemia, Acute
- Stem Cell Transplant Complications
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
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 ...
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 10 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.
Tracking Information
- NCT #
- NCT04678401
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: John Koreth, MBBS, DPhil Dana-Farber Cancer Institute