Lupus & antiphospholipid syndrome

Local immune effector cell-associated toxicity syndrome in chimeric antigen receptor (CAR) T-cell treated patients with autoimmune disease: an observational study

Lancet RheumatolPublished Observational study

Authors' conclusion

LICATS is a new form of toxicity in patients with autoimmune disease receiving CD19-targeting CAR T-cell therapy, most likely based on the cleansing of immune cells from the affected organs. It is self-limited, organ-specific, and usually mild in its intensity.

Study context

Population
Patients of any age with autoimmune disease receiving CD19-targeting CAR T-cell therapy, two centres in Germany, March 2021–Oct 202425 (64%) female
Participants
39 patients
Exposure
Systemic lupus erythematosus (SLE) vs SSc vs IIM
  • SLEn = 20
  • SScn = 13
  • IIMn = 6
Outcome
Local organ-specific reactions after CAR T-cell infusion (LICATS), graded for severity
Methodological detailstwo centres in Germany, follow-up of at least 30 days, People with related lived experience were involved in the study design and implementation
  • Two centres in Germany
  • Follow-up of at least 30 days
  • People with related lived experience were involved in the study design and implementation

Main finding

As reported in the abstract

LICATS (local immune effector cell-associated toxicity syndrome)
Local reactions recorded
54
Patients affected
30 (77%)
Median time of onset from infusion, days (IQR 9-21)
10
Median duration, days (5-14)
11
Skin affected, of 54
19 [35%]
Kidneys affected
12 [22%]
Grade 1
35 [65%]
Grade 2
16 [30%]

Observational data: associations, not effects.

Original publication

Local immune effector cell-associated toxicity syndrome in CAR T-cell treated patients with autoimmune disease: an observational study. Lancet Rheumatol. Published 30 April 2025. doi:10.1016/s2665-9913(25)00091-8

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