Tr1X Announces FDA Clearance of IND Application for TRX103, an Allogeneic Engineered Tr1 Treg Cell Therapy for Treatment-Refractory Crohn’s Disease.

Published on 7 August 2024

SAN DIEGO, Aug. 07, 2024 (GLOBE NEWSWIRE) — Tr1X, Inc. (pronounced “Trix”), a biopharmaceutical company specializing in allogeneic engineered Treg and CAR-Treg cell therapies with the potential to cure autoimmune and inflammatory diseases, announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for TRX103, an engineered Tr1 Treg cell therapy for treatment-refractory Crohn’s Disease. TRX103 is currently being tested in a Phase 1/2a trial in patients undergoing hematopoietic stem cell transplant (HSCT) for hematological malignancies.

Explore posts connected to this topic

Tr1X to Present New Clinical and Preclinical Data on Engineered Tr1 Treg Cell Therapies at ASGCT 2026

SAN DIEGO–(BUSINESS WIRE)–Tr1X, Inc., a clinical-stage autoimmune and inflammatory disease company developing Type 1 regulatory T (Tr1) cell therapies, today...

Press Releases

May 8, 2026

Bag of Tr1Xs: Off-the-Shelf Type 1 Treg Shows Phase I Promise for GvHD

In a clinical first, Tr1X Bio showed immune reconstitution and

Interviews

February 11, 2026

Tr1X Presents First Clinical Data Demonstrating Proof of Safety and Proof of Mechanism With Allogeneic Off-the-Shelf Tr1 Regulatory T Cell Therapy TRX103

First clinical data from Phase 1 dose-escalation study in patients

Press Releases

February 4, 2026

SAN DIEGO–(BUSINESS WIRE)–Tr1X, Inc., a clinical-stage autoimmune and inflammatory disease

Press Releases

May 8, 2026