Welcome to the February 2019 TREGeneration newsletter!
In this fourth issue we summarize TREGeneration project progress over the past 12 months, plus project plans and dissemination opportunities for the future.
By far the most significant TREGeneration news this year has been the inclusion of a new partner and new clinical trial, led by Professor José Antonio Pérez-Simón for the Andalusian Health Service, Spain (SAS). Prof. Pérez-Simón is Head of the Department of Hematology at University Hospital Virgen del Rocio and Research Coordinator at the Biomedical Research Institute of Seville (IBiS). Both institutes will now be involved in the TREGeneration project.
The Seville-cGVHD trial will investigate the same dose-escalation Treg infusion study protocol as the Lisbon-cGVHD trial, but in a cohort of patients who obtained partial response after treatment with ruxolitinib, a JAK2 inhibitor. The aim is for Treg infusions to be employed as an alternative to increasing immunosuppressants, to increase the Complete Remission rate compared to ruxolitinib alone. Each TREGeneration’s current trials employs a slightly different protocol/scientific question (all infuse donor Tregs but these products may be expanded/not expanded, with different adjuvants or at different doses) and so this new trial fits well within this group. As in all of the consortium’s trials, patients will be clinically evaluated for treatment safety and preliminary efficacy and immunologically monitored over time, using consortium-wide standardized measures. Data obtained will also feed into the multivariate analysis framework towards the end of the project.
Prof. Pérez-Simón will be joined by Dr. Patricia Garcia, coordinator of the clinical trials unit, Dr. Virginia Escamilla, responsible for blood banking, Dr. Teresa Caballero, responsible for the department of flow cytometry, Dr. Cristina Calderon, responsible for the cell selection/cryopreservation, Dr. Nancy Rodriguez, consultant in the transplantation unit, Dr. Ildefonso Espigado, head of the clinics of the department of hematology, Dr. Estefania Garcia Guerrero and Dr. Alfonso Rodriguez Gil, both postdoctoral researchers in the Cell Therapy Lab and Clara Garcia, postdoctoral researcher in the Flow Cytometry lab.
We are excited to welcome the whole team onboard and looking forward to seeing their results!
General assembly 2018
Back in March 2018 all TREGeneration partners met once again for the annual consortium meeting, this time held at the coordinating institution, Instituto de Medicina Molecular (IMM) in Lisbon, Portugal.
Topics discussed included how best to visually report clinical responses (WP2) and how to organise our clinical and immune monitoring data for the Multivariate Analysis to be conducted by Marta García-Fiñana’s team at UoL (WP5). As part of WP4 (Next Gen Sequencing), Dr. Hans-Jörg Warnatz (MPIMG) presented clonotype diversity data from patient samples, demonstrating that infused Tregs can be tracked over time and preliminarily identifying critical timepoints for clonotype expansions. We were lucky to be able to host SAB member Prof. Jerome Ritz from the Dana-Farber Cancer Institute/Harvard Stem Cell Institute who presented an interesting overview of ongoing cGVHD trials, including Treg + IL-2 (Phase I) and IL-2 Intra-patient Dose Escalation (Phase I), functional studies and T cell receptor repertoire analyses. All in all a productive meeting!.
Consortium Participation at ASH 2018
The TREGeneration Consortium did not miss the opportunity to be present at the American Society of Hematology (ASH), 1st-4th December 2018, San Diego, USA, where we presented the poster entitled “Profiling T Cell Receptor Repertoires in Phase I/II Clinical Trials of Donor Treg Infusion for the Treatment of Chronic Graft-versus-Host Disease” Published in Blood 2018 132:4563.
Our partners will make use of the following upcoming opportunities to disseminate the project:
- TREGeneration General Assembly 14th-15th Feb 2019, Seville, Spain
- EBMT, 24th-27th March 2019, Frankfurt, Germany
- American Society of Hematology (ASH), 7th-8th December 2019, Orlando, USA
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