ARM008 / TriArm Therap - LARVOL DELTA

First-in-Human Non-Viral Bispecific BCMA/CD19 CAR-T in Refractory SLE, SSc, and SS: Safety, Dual Pharmacodynamics, and Immune Reset (ACR Convergence 2026) - "Lymphodepletion was fludarabine/cyclophosphamide 25/250 mg/m²/day ×3; dose was 1×10⁵/kg (n=3) or 3×10⁵/kg (n=2)... In this first-in-human Phase 1 trial, non-viral BCMA/CD19 bispecific CAR-T showed feasible manufacturing, Grade 1-only CRS, no ICANS, and rapid dual-lineage PD activity across SLE, SSc, and SS, including, to our knowledge, the first reported CAR-T-treated Sjögren's disease patient. Early organ-level signals were observed, particularly in SSc/ILD, while SLE/LN showed discordant clinical-serologic dynamics. Autoantibody repertoire changes support immune reshaping and proof of concept for non-viral dual-target immunodepletion."

Bispecific • CAR T-Cell Therapy • Clinical • First-in-human • IO biomarker • P1 data • PK/PD data • Hematological Disorders • Inflammatory Arthritis • Leukopenia • Neutropenia • Renal Disease • Sjogren's Syndrome • Systemic Sclerosis