News Update Immorna Announces First Evidence of Tissue B Cell Depletion with In Vivo CAR T JCXH 213 in Systemic Sclerosis Patient, Underscoring Platform’s Potential to Address Autoimmune Diseases
Release time:
2026-04-09
Hangzhou, CHINA – April 10, 2026 – Immorna, a clinical-stage biotechnology company pioneering next‑generation RNA therapeutics, today announced updated clinical data for JCXH‑213, its novel CD19-targeted in vivo CAR‑T candidate, demonstrating thorough B‑cell depletion in peripheral blood and lymph node tissues in a patient with Systemic Sclerosis (SSc). This marks the first reported evidence of deep tissue B‑cell depletion with an in vivo CAR‑T approach and highlights the unique capabilities of Immorna’s active‑targeting lipid complex nanoparticle (tLCNP) platform.
“Systemic Sclerosis is a devastating autoimmune disease where pathogenic B cells drive fibrosis and organ damage,” said Dr. Yuanqing Liu, CSO of Immorna. “Achieving complete B‑cell depletion not only in blood but also in lymphoid tissues with a redosable, well‑tolerated in vivo CAR‑T therapy represents a significant milestone. These data support the potential of JCXH‑213 to provide curative clinical benefits in autoimmune patients without the need for preconditioning chemotherapy or the logistical burden of ex vivo cell manufacturing.”
Complete B‑Cell Depletion in Blood and Lymph Node in First SSc Patient
In an ongoing clinical study, the first patient with systemic sclerosis received low doses of JCXH‑213. Peripheral B‑cell counts dropped to undetectable levels after a single administration and remained undetectable throughout the two‑week treatment period. Autoantibody levels also dropped following treatment.
Critically, biopsy assessment confirmed thorough B‑cell depletion in lymph node tissue—a key reservoir of autoreactive B cells—demonstrating that the active-targeting tLCNP platform effectively delivers the CAR payload to T cells capable of trafficking to and eliminating B cells in lymphoid compartments. These tissue findings represent a first‑in‑class achievement for an in vivo CAR‑T candidate. It is worth noting that B-cell depletion in lymph node tissue has been more difficult to achieve than in bone marrow, based on non-human primate (NHP) data.
No Cytokine Release Syndrome or Liver Toxicity Observed
JCXH‑213 was well tolerated in the SSc patient, with no signs of cytokine release syndrome (CRS) nor abnormal liver enzyme elevation. No treatment-related adverse event was reported throughout the treatment. This favorable safety profile has been consistent across all patients treated to date, including those with B‑cell lymphoma and other autoimmune indications.
Active‑Targeting LNP Platform Drives Differentiation
JCXH‑213 utilizes Immorna’s proprietary active‑targeting tLCNP, which incorporates a chemically conjugated proprietary CD8 nanobody to preferentially transfect CD8⁺ T cells. In addition, the tLCNP has demonstrated good spleen tropism and high efficiency to transfect naïve T cells. In non‑human primate studies, this active‑targeting formulation achieved faster and more thorough B‑cell depletion at low doses compared to a passive‑targeting LNP, with only transient, mild elevations of liver enzymes and minimal cytokine elevation.
The active‑targeting tLCNP is central to Immorna’s in vivo CAR‑T strategy, enabling efficient T‑cell transfection, deep B‑cell elimination, and a favorable safety profile without the need for lymphodepletion or immunosuppressive preconditioning.
Scalable Manufacturing and Pipeline Expansion
Immorna has established a robust manufacturing process for JCXH‑213 and comprehensive analytical characterization/ release assay panel, with current batch scale supporting 3,000 doses per batch and a pathway to expand to 20,000 doses or more while maintaining consistency. Formulation enhancements have significantly improved stability of JCXH-213 at intended storage conditions.
Building on these results, Immorna is enrolling additional patients with autoimmune diseases, including systemic lupus erythematosus (SLE), immune thrombocytopenic purpura (ITP) and systemic sclerosis. Preclinically, Immorna is quickly advancing next‑generation constructs incorporating self‑replicating RNA and novel CAR targets.
About JCXH‑213
JCXH‑213 is an investigational in vivo CAR‑T therapy that uses mRNA‑LNP technology to generate CD19-targeting CAR‑positive T cells directly in the patients. The candidate incorporates Immorna’s proprietary active‑targeting tLCNP platform designed to preferentially transfect CD8⁺ T cells. JCXH‑213 is being evaluated in B‑cell malignancies and autoimmune diseases.
About Immorna
Immorna is a clinical‑stage biotechnology company focused on developing next‑generation RNA therapeutics. Leveraging proprietary delivery and manufacturing platforms supported by a robust IP portfolio, Immorna is advancing a pipeline of in vivo cell therapies and mRNA‑based medicines to address serious diseases with high unmet medical need.
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