TRX319 / Tr1X - LARVOL DELTA

TRX319 is a novel CAR-Tr1 Treg cell therapy with dual targeting of B cells and T cells for the treatment of progressive multiple sclerosis. (ASGCT 2026) - No abstract available

CAR T-Cell Therapy • CNS Disorders • Multiple Sclerosis

IMPACT-MS: Treatment of Participants With Primary or Secondary Progressive Multiple Sclerosis (clinicaltrials.gov) - P1/2 | N=39 | Recruiting | Sponsor: Tr1X, Inc.

New P1/2 trial • CNS Disorders • Multiple Sclerosis

TRX319: A Novel Regulatory T-Cell Therapy with Dual Targeting of B Cells and T Cells in Progressive MS (ACTRIMS Forum 2026) - "TRX319 is a novel cell therapy with a dual mechanism of action designed to target both B and T cells in pMS. Preclinical data demonstrate that TRX319 possesses potent CD19-CAR mediated B cell depletion with enhanced persistence compared to effector CD3+ CAR-T cells, while simultaneously suppressing autoreactive CD4+ T cells. A Phase I/2a dose escalation trial of TRX319 for the treatment of primary and secondary pMS is currently recruiting patients."

IO biomarker • CNS Disorders • Hematological Malignancies • Leukemia • Multiple Sclerosis • Solid Tumor • CD4 • IFNG • IL10 • IL22 • MBP • NGFR • TNFA

Tr1X Announces FDA Clearance of IND Application for TRX319, a First-in-Class Allogeneic CAR-Tr1 Treg Cell Therapy for Progressive Multiple Sclerosis… (Yahoo Finance) - "On track to initiate TRX319 Phase 1/2a dose-escalation trial in early 2026."

IND • New P1/2 trial • Multiple Sclerosis

Tr1X Announces…$50 Million in Additional Financing (Yahoo Finance) - "...Allowing Tr1X to advance the TRX319 Phase 1/2a study and the ongoing TRX103 Phase 1/2a trial for patients with refractory Crohn’s disease."

Financing • Crohn's disease • Multiple Sclerosis