Ignite Creation Date:
2024-05-06 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04678401
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2020-12-16
Brief Title:
IS-free Treg HaploHCT
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A PilotPhase 1 Study of Immunosuppression-free Regulatory T-cell Graft-engineered Haploidentical Hematopoietic Cell Transplantation in RelapsedRefractory and Ultra-High-risk AMLMDS
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is evaluating the safety and efficacy of the IS-free Treg-cell graft-engineered haplo transplant method in people with relapsedrefractory and Ultra-high risk acute myeloid leukemia AML andor 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
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
Detailed 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 eg 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None