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Clinical Trial Summary

Reduced intensity conditioning (RIC) has emerged and been increasingly adopted as a modality to allow preparative conditioning pre transplant to be tolerated by older adults or those patients that are otherwise unfit for myeloablative conditioning. In this study, we aim to use RIC followed by matched related/unrelated donor, 7/8 matched related/unrelated donor, or haploidentical donor peripheral blood stem cell transplantation. Standard strategies to control the alloreactivity following HCT utilize immunosuppressive or cytotoxic medications. In this study, we explore donor graft engineering to enrich for immmunoregulatory populations to facilitate post transplantation immune reconstitution while minimizing graft versus host disease (GVHD) with post-transplant immunosuppressive agents.


Clinical Trial Description

The objectives for the study are listed below: Primary Objectives *Determine the safety, and feasibility of administration of several dose combinations of conventional T-cells (Tcon) and regulatory T-cells (Treg) in subjects undergoing allogeneic hematopoietic cell transplantation (HCT) with related/unrelated HLA-matched or mismatched donors, or haploidentical donors with reduced intensity conditioning preparative regimen. Secondary Objectives - To determine the GVHD-free relapse-free survival (GRFS) post-HCT - To determine the overall survival (OS) post-HCT - To measure the incidence and severity of acute and chronic GVHD Exploratory Objectives - To measure the incidence of serious infections - To measure the incidence and timing of engraftment - To measure T cell immunity reconstitution parameters ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05088356
Study type Interventional
Source Stanford University
Contact Lindsay Danley
Phone 650-736-0304
Email lindsmd@stanford.edu
Status Recruiting
Phase Phase 1
Start date September 7, 2021
Completion date December 2025

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