| Title: |
Engineered Treg Donor Cell Therapy to Prevent Graft-Versus-Host Disease |
| Authors: |
Meyer, Everett; Pavlova, Anna; Muffly, Lori; Sutherland, Katherine; Bader, Cameron; Bharawaj, Sushma; Dahiya, Saurabh; Frank, Matthew; Arai, Sally; Johnston, Laura; Miklos, David; Rezvani, Andrew; Shiraz, Parveen; Sidana, Surbhi; Shizuru, Judith; Weng, Wen-kai; Agrawal, Vaibhav; Putnam, Amy; Ferhnoff, Nathaniel; Tamaresis, John; Lu, Ying; McClellan, Scott; Lowsky, Robert; Negrin, Robert; error, error |
| Publisher Information: |
Springer Science and Business Media LLC |
| Publication Year: |
2024 |
| Description: |
Allogeneic hematopoietic cell transplantation (HCT) is a curative therapy limited by graft-versus-host disease (GVHD). Donor regulatory T cells (Tregs) appear to prevent GVHD and promote healthy immunity. We have developed a high-precision Treg cell therapy manufactured from donor mobilized peripheral blood. We conducted an open-label, single-center, phase 2 efficacy study investigating if the use of a precision engineered donor Treg cell therapy improves one-year GVHD-free relapse free survival (GRFS) after myeloablative transplantation. Thirty-three patients with HLA-matched donors were enrolled. All donor Treg cell products were successfully manufactured and administered fresh within 72 hours. One-year incidence of acute grade III-IV GVHD of 6%, moderate to severe chronic GVHD of 7% and non-relapse mortality rate of 6%. The primary endpoint of significantly improved one-year GRFS was achieved at 67% for HLA-matched patients compared to a predicted 40% (p < 0.002). Trial participants had a reduced incidence of GVHD and improved GRFS, as compared to rates common to highly variable unmanipulated donor grafts and multi-agent immune suppression. |
| Document Type: |
other/unknown material |
| Language: |
unknown |
| DOI: |
10.21203/rs.3.rs-3835158/v1 |
| Availability: |
http://dx.doi.org/10.21203/rs.3.rs-3835158/v1; https://www.researchsquare.com/article/rs-3835158/v1; https://www.researchsquare.com/article/rs-3835158/v1.html |
| Rights: |
https://creativecommons.org/licenses/by/4.0/ |
| Accession Number: |
edsbas.D778EE71 |
| Database: |
BASE |