Tr1X Announces First Patient Dosed in Proof of Concept GvHD Trial Evaluating TRX103, a First-in-Class Type 1 Treg (Tr1) Cell Therapy

TRX103 is designed to reset the immune system, improve clinical outcomes, and potentially cure patients suffering from autoimmune and inflammatory disorders

  • This marks the first use of an allogeneic engineered Type 1 Treg (Tr1) cell therapy in clinical trials.
  • The first patient has successfully cleared the safety period with no serious adverse events.
  • Additional preliminary safety and effectiveness data readouts expected by Q4 2024.

SAN DIEGO, July 10, 2024 (GLOBE NEWSWIRE) — Tr1X, Inc. (pronounced “Trix”), a biopharmaceutical company developing engineered Treg and CAR-Treg cell therapies, announced the successful dosing of the first patient in the company’s TRX103-01 proof of concept trial for prevention of Graft versus Host Disease (GvHD) and improved outcomes in patients with hematologic malignancies undergoing mismatched hematopoietic stem cell transplantation (HSCT).

The study’s primary goal is to determine the safety, pharmacokinetics and pharmacodynamics of TRX103. The secondary goal of the study is to create immune tolerance to prevent GvHD and improve HSCT outcomes. The first patient had no serious adverse events, and the multi-center dose escalation trial continues to enroll.

TRX103, a first-in-class Type 1 Treg (Tr1) cell therapy, is specifically designed for patients with autoimmune and inflammatory disorders, including those undergoing HSCT. TRX103 is an off-the-shelf, engineered Type 1 Treg (Tr1) cell therapy designed to reduce inflammation, prevent harmful T cell proliferation, and reset the immune system. This therapy harnesses unique properties of Tr1 cells that include trafficking to inflamed tissues and lymph nodes, lowering of inflammatory cytokines, control of harmful T cell responses, and creation of immune tolerance.

Compared to other cell therapies, such as effector CAR-T cells, TRX103 Treg cells aim to treat autoimmune diseases with fewer side effects, potentially without the need for lymphodepletion. These cells are naturally shielded from the immune system, enhancing their persistence and minimizing potentially dangerous immune response.

“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,” said Maria Grazia Roncarolo, Co-founder, President and Head of Research and Development at Tr1X. “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.”

The TRX103-01 study builds on academic research that has shown the safety and efficacy of Tr1 Treg cell therapies for various autoimmune and inflammatory conditions, including prevention of GvHD and treatment of severe inflammatory bowel disease. The company has produced enough clinical doses from its first manufacturing runs using its proprietary closed process to complete the trial, which is designed to treat up to 36 patients with a one-time infusion of TRX103.

Tr1X also plans to file an IND for TRX103 for treatment-refractory Crohn’s Disease in the second half of 2024.

About TRX103
TRX103 is an investigational allogeneic off-the-shelf engineered T cell product generated from CD4+ cells sourced from healthy donors. These CD4+ cells are engineered to become cells that mimic the function of Tr1 regulatory T cells, called TRX cells. Tr1X is developing TRX103 for the treatment of several immune and inflammatory disorders. Multiple preclinical studies have shown TRX103 to be tolerable and effective and to have the potential to reset the immune system to a healthy state. TRX103 has the potential to overcome major limitations of current cell therapies for autoimmune diseases, which include limited persistence and side effects including cytokine release syndrome (CRS) and neurotoxicity.

About Tr1X
Tr1X is a private biotechnology company focused on curing immune mediated and inflammatory diseases. Founded by industry experts, including the scientists who discovered Tr1 cells, the company is developing a pipeline of off-the-shelf allogeneic cell therapies to treat and potentially cure autoimmune diseases with high unmet medical need. The company is supported by leading investors, including The Column Group, NEVA SGR, and Alexandria Venture Investments, and has received additional grant support from the California Institute for Regenerative Medicine (CIRM). For more information, visit

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