Time of onset, severity, and localization of LICATS. Credit score: The Lancet Rheumatology (2025). DOI: 10.1016/S2665-9913(25)00091-8
Researchers at Friedrich-Alexander-Universität Erlangen-Nürnberg have recognized a beforehand undocumented, organ-specific toxicity linked to CD19-targeted CAR T-cell remedy in autoimmune illness. The syndrome, termed native immune effector cell-associated toxicity syndrome (LICATS), affected 77% of sufferers and resolved with out lasting problems.
B-cell-driven autoimmune ailments resembling systemic lupus erythematosus, systemic sclerosis, and idiopathic inflammatory myopathy harm organs by means of extended immune cell infiltration and antibody accumulation. Typical therapies suppress immune activation however typically fail to revive lasting immunologic tolerance.
Circulating B cells could be focused by monoclonal antibodies, but this method doesn’t attain immune cells embedded deep inside tissues. Organs such because the kidney, lung, and muscle proceed to deteriorate underneath native irritation, even when blood-based B-cell markers decline.
CAR T-cell remedy introduces genetically modified immune cells able to penetrating tissue and eliminating CD19-positive B cells in affected websites. Stories of drug-free remission in sufferers handled with this method have intensified medical curiosity.Toxicities noticed in most cancers trials dominate the chance profile, leaving clinicians unsure about potential autoimmune-specific problems.
Within the research, “Local immune effector cell-associated toxicity syndrome in CAR T-cell treated patients with autoimmune disease,” printed in The Lancet Rheumatology, investigators performed an observational evaluation to doc organ-focused reactions following CD19 CAR T-cell infusion.
LICATS and its decision within the pores and skin and lungs. Credit score: The Lancet Rheumatology (2025). DOI: 10.1016/S2665-9913(25)00091-8
A complete of 39 adults and adolescents obtained the second-generation CD19 CAR merchandise, MB-CART 19.1 or KYV-101, at Erlangen and Düsseldorf facilities between March 2021 and October 2024, then entered at the least 30-day follow-up.
Clinicians tracked native signs, laboratory shifts, imaging, and biopsy outcomes, grading occasions from 1 (self-resolving) to 4 (intensive care) and classifying onset as early, intermediate, or late. Investigators excluded systemic cytokine launch syndrome (CRS) and required spontaneous regression or temporary glucocorticoid use to separate LICATS from illness flare.
In all, 54 LICATS occasions emerged throughout 30 sufferers, most frequently pores and skin eruptions (35%) and kidney dysfunction (22%). Median onset registered at 10 days after infusion, lasting a median of 11 days. All occasions occurred throughout B-cell aplasia and solely in organs beforehand concerned in every affected person’s autoimmune illness.
Some 65% of episodes resolved with out remedy, 30% responded to quick glucocorticoid tapers, and solely three occasions prompted rehospitalization. Three occasions, all categorized as grade 3, led to prolonged hospitalization. No sufferers required intensive care, and all LICATS occasions resolved with out long-term impairment.
Researchers conclude that LICATS represents a self-limiting type of organ-specific toxicity arising after CD19-targeted CAR T-cell remedy in autoimmune illness. Occasions resolved spontaneously or with temporary glucocorticoid remedy and didn’t sign recurrence of underlying illness.
Consciousness of LICATS could assist clinicians keep away from pointless long-term immunosuppression in sufferers who develop post-treatment signs localized to beforehand affected organs.
Extra data:
Melanie Hagen et al, Native immune effector cell-associated toxicity syndrome in CAR T-cell handled sufferers with autoimmune illness: an observational research, The Lancet Rheumatology (2025). DOI: 10.1016/S2665-9913(25)00091-8
Samuel D Good et al, A brand new toxicity syndrome in sufferers with autoimmune illness handled with CAR T-cell remedy, The Lancet Rheumatology (2025). DOI: 10.1016/S2665-9913(25)00100-6
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