TRX103 is being developed for a range of immune and inflammatory disorders. Credit: PeopleImages.com – Yuri A/Shutterstock.

Tr1X has dosed the first patient as part of the TRX103-01 clinical trial to assess TRX103, a Type 1 Treg (Tr1) cell therapy for Graft versus Host Disease (GvHD) prevention.

The trial aims to evaluate the safety, pharmacokinetics, and pharmacodynamics of TRX103 for the prevention of GvHD in patients with hematologic malignancies undergoing mismatched hematopoietic stem cell transplantation (HSCT).

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Additionally, the trial seeks to establish immune tolerance to prevent GvHD and enhance HSCT outcomes.

The initial patient reported no serious adverse events, and the trial, which involves multiple centres and a dose-escalation approach, is actively recruiting further participants.

TRX103 is said to be a first-in-class Tr1 cell therapy tailored for individuals with autoimmune and inflammatory conditions, including those undergoing HSCT.

This off-the-shelf engineered therapy is designed to mitigate inflammation, inhibit harmful T-cell proliferation, and recalibrate the immune system.

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Tr1 cells are known for their ability to migrate inflamed tissues and lymph nodes, reduce inflammatory cytokines, control detrimental T cell responses, and foster immune tolerance.

The TRX103-01 study is supported by academic research that has demonstrated the safety and effectiveness of Tr1 Treg cell therapies in various autoimmune and inflammatory conditions.

This includes the prevention of GvHD and the treatment of severe inflammatory bowel disease.

Tr1X successfully produced sufficient clinical doses from its initial manufacturing runs, utilising a closed process to complete the trial.

The study is designed to treat up to 36 patients with a single infusion of TRX103.

Tr1X is preparing to submit an Investigational New Drug (IND) application for TRX103 as a treatment for refractory Crohn’s Disease in the latter half of 2024.

Tr1X co-founder, president, and research and development head Maria Grazia Roncarolo said: “This first patient to receive an allogeneic engineered Tr1 cell therapy, TRX103, is a significant achievement for our company, our scientists, and the field of cell and gene therapy.

“This is a key step in advancing our pipeline. We believe our allogeneic Tr1 Treg and CAR-Treg therapies can overcome the limitations of current treatments by controlling harmful T cells and B cells and creating immune tolerance, potentially curing a wide range of autoimmune and inflammatory disorders.

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