Phase 1 Trial of ALLO-329, a Dual Anti-CD19Anti-CD70 Allogeneic CAR T Cell Therapy, to Assess Safety and Early Effectiveness in Adults with Autoimmune Diseases

What this Trial Is About

Researchers are evaluating ALLO-329, an allogeneic dual anti-CD19anti-CD70 CAR T cell therapy, in adults with autoimmune diseases including systemic lupus erythematosus SLE with and without kidney involvement, idiopathic inflammatory myopathy IIM, and systemic sclerosis SSc. This first-in-human, open-label, single-arm study aims to assess the safety, tolerability, and initial biological activity of ALLO-329 and to determine the appropriate dosing regimen for future phases of research. Participants receive ALLO-329 either alone or following a chemotherapy-based lymphodepletion regimen that includes cyclophosphamide alone or combined with fludarabine. The study uses a sequential design to evaluate these different treatment approaches and monitor how the therapy behaves in the body over time. The trial focuses on safety and clinical response to the treatment, observing participants for up to 60 months. During the study, participants undergo scheduled visits for treatment, laboratory tests, and evaluation of disease activity based on established criteria for SLE, IIM, or SSc. Researchers will monitor safety by tracking dose-limiting toxicities and other parameters, as well as assess disease responses specific to each autoimmune condition. The study also measures the expansion and persistence of the ALLO-329 cells over time, with follow-up lasting up to five years to evaluate long-term safety and treatment effects.

A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease