Immorna, a Hangzhou-based clinical-stage biotechnology company, reported early clinical data for JCXH-213, its CD19-targeted in vivo CAR-T candidate, in a single patient with systemic sclerosis, with findings showing peripheral and lymph node B-cell depletion following a low-dose single administration over a two-week observation period. The company said no cytokine release syndrome or liver enzyme abnormalities were observed in the treated patient.
Peripheral B-cell counts fell to undetectable levels after a single administration and remained undetectable throughout the two-week treatment period, according to Immorna. Autoantibody levels also declined following treatment, though no quantitative values were disclosed. Biopsy assessment of lymph node tissue confirmed B-cell depletion at that site, which Immorna described as a first for an in vivo CAR-T approach, noting that lymph node depletion has proven harder to achieve than bone marrow depletion in prior non-human primate studies. No treatment-related adverse events, CRS, or abnormal liver function tests were reported. The company stated this safety profile has been consistent across all patients treated to date across indications including B-cell lymphoma and other autoimmune diseases, though aggregate patient numbers were not disclosed.
The ongoing study (NCT06564194) is enrolling patients across multiple autoimmune indications including systemic lupus erythematosus, immune thrombocytopenic purpura, and systemic sclerosis, with the data reported here drawn from a single SSc patient. The trial phase was not stated in the source material, exact dosing was described only as "low doses," and no primary endpoint was disclosed. The data are based on one patient over a two-week window, and no control arm or comparative cohort was described.
JCXH-213 delivers CAR-encoding mRNA via a proprietary active-targeting lipid complex nanoparticle conjugated to a CD8 nanobody, designed to preferentially transfect CD8-positive T cells in vivo without ex vivo cell manufacturing or lymphodepleting preconditioning. No established standard-of-care therapy has demonstrated comparable B-cell depletion in lymphoid tissue in systemic sclerosis; rituximab, an anti-CD20 monoclonal antibody, has been used off-label in SSc but has not shown consistent efficacy in controlled trials. Cross-trial comparisons are limited by differences in study design, duration, and patient populations.
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