HN2301 / Shenzhen MagicRNA Biotechnology - LARVOL DELTA

Deep Depletion of Tissue-Resident B Cells by in vivo CD19 CAR T-Cell Therapy (HN2301) Induces Profound Clinical Remission in Patients with Systemic Lupus Erythematosus. (ACR Convergence 2026) - No abstract available

CAR T-Cell Therapy • Preclinical • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Efficacy and Safety of HN2301 in Patients With Generalized Myasthenia Gravis (MG) (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Shenzhen MagicRNA Biotechnology Co., Ltd | Trial completion date: Dec 2027 ➔ Dec 2028 | Initiation date: May 2026 ➔ Dec 2026

Trial completion date • Trial initiation date • CNS Disorders • Myasthenia Gravis

In Vivo CD19 CAR T-cell therapy Induces tissue B‑cell depletion in Systemic Lupus Erythematosus (EULAR 2026) - "Lipid nanoparticle (LNP)‑based in vivo CAR T-cell (HN2301) therapy, successfully generates CD19‑targeting CAR T-cells in patients with systemic lupus erythematosus (SLE), leading to peripheral B‑cell depletion and decrease of disease‑associated autoantibodies...All of the patients are well tolerated and no high grade cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome were observed. Conclusions This study demonstrates that LNP‑based in vivo CAR T-cell therapy has potential to achieve deep B‑cell depletion in lymphoid tissues and bone marrow thus induce immune reset and durable clinical remission in patients with SLE."

CAR T-Cell Therapy • Preclinical • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

In Vivo CD19 CAR T-cell therapy Induces tissue B‑cell depletion in Systemic Lupus Erythematosus (ASGCT 2026) - "B. CD19 staining of lymph node from a positive control lupus patient and a patient after HN2301 treatment by immunohistochemistry."

CAR T-Cell Therapy • Preclinical • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Efficacy and Safety of HN2301 in Patients With Generalized Myasthenia Gravis (MG) (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Shenzhen MagicRNA Biotechnology Co., Ltd

New P1 trial • CNS Disorders • Myasthenia Gravis

Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs） (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Shenzhen MagicRNA Biotechnology Co., Ltd | Phase classification: P=N/A ➔ P1 | Trial completion date: Dec 2026 ➔ Jun 2028 | Trial primary completion date: Dec 2026 ➔ Dec 2027

Phase classification • Trial completion date • Trial primary completion date • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis

Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs） (clinicaltrials.gov) - P=N/A | N=30 | Recruiting | Sponsor: Shenzhen MagicRNA Biotechnology Co., Ltd | Trial completion date: Mar 2026 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis

Efficacy and Safety of HN2301 in Refractory Myasthenia Gravis(MG) (clinicaltrials.gov) - P=N/A | N=9 | Terminated | Sponsor: Shenzhen MagicRNA Biotechnology Co., Ltd | Trial completion date: Dec 2026 ➔ Feb 2026 | Initiation date: Jun 2025 ➔ Jan 2026 | Recruiting ➔ Terminated | Trial primary completion date: May 2026 ➔ Feb 2026; Change of registrant

Trial completion date • Trial initiation date • Trial primary completion date • Trial termination • CNS Disorders • Myasthenia Gravis