Engineering allogeneic type 1 regulatory T cells: a scalable, off-the-shelf platform for restoring immune tolerance
By
Molly Javier Uyeda
Audrey Re
Chunyi Tang
Melissa McLaughlin
Daryl Humes
Steven Sexton
Robert Freeborn
Isaura Villalba
Kevin Nugent
James Adams
Jie Wei
Matt Breton
Xavier Paliard
Maximilian Richter
Maria Grazia Roncarolo
Ryan Bjordahl
July 9, 2026
Clinical Scorecard: Development of Allogeneic Type 1 Regulatory T Cells: A Scalable Off-the-Shelf Solution for Restoring Immune Tolerance
At a Glance
Category Detail
Condition Type 1 regulatory T (Tr1) cell therapy Key Mechanisms IL-10 production, suppression of effector T cell proliferation, inhibition of pro-inflammatory cytokine production Target Population Patients with Crohn’s disease and graft-versus-host disease (GvHD) Care Setting Clinical development and trials
Key Highlights
TRX103 is an engineered allogeneic Tr1 cell therapy manufactured under Good Manufacturing Practice. In vitro, TRX103 suppressed effector T cell proliferation and inhibited cytokine production. In vivo, TRX103 prevented disease development in a xenogeneic GvHD model. TRX103 is currently being evaluated in Phase 1/2a and Phase I studies for Crohn’s disease and GvHD prevention. Guideline-Based Recommendations
Diagnosis
Evaluate patients for Crohn’s disease and GvHD based on clinical criteria. Management
Consider TRX103 for treatment-refractory Crohn’s disease and GvHD prevention. Monitoring & Follow-up
Monitor for clinical response and potential adverse effects during TRX103 therapy. Risks
Potential risks include immune response to allogeneic cells and cytokine release syndrome. Patient & Prescribing Data
Patients with treatment-refractory Crohn’s disease and those undergoing hematopoietic stem cell transplantation.
TRX103 provides a scalable off-the-shelf solution for immune-mediated diseases.
Clinical Best Practices
Utilize engineered Tr1 cells to achieve localized IL-10 delivery in inflamed tissues. Ensure compliance with manufacturing standards for cell therapy products. Related Resources & Content
