Lupus & antiphospholipid syndrome

Heterogeneous responses of IM19 anti-CD19 chimeric antigen receptor (CAR) T-cell therapy in refractory systemic lupus erythematosus: an open-label pilot study and a mini-review

Ann Rheum DisPublished Open-label single-arm pilot clinical trial with mini-review

Authors' conclusion

IM19 CAR T-cell therapy demonstrated a favourable safety profile and clinically meaningful systemic improvement. Responses to CAR-T therapy in LN were variable. Chronic renal manifestations, podocytopathy, and ageing were associated with suboptimal therapeutic outcome.

Study context

Population
Patients with refractory systemic lupus erythematosus (SLE) and renal involvement
Participants
6 patients
Outcome
SLEDAI-2K score
Follow-up
Day 90 and day 180

Main finding

As reported in the abstract

Median SLEDAI-2K at baseline (range 10-24)

12

Median SLEDAI-2K at day 90 (range 2-8)

4

Median SLEDAI-2K at day 180 (range 2-6)

5

Further findings

Renal response

Complete responders
2
Partial responders
2
Nonresponders
2
  • Heterogeneous

Repeat renal biopsies (day 180)

No B-cell infiltration, but dominant chronic changes and podocytopathies post-CAR-T

B-cell reconstitution (single-cell analysis)

Patients with B-cell reconstitution
3/6

Mini-review: renal complete response rate of CAR-T therapy in lupus nephritis (LN)

Renal complete response rate
72.4%
Advanced age associated with suboptimal response

Safety

OutcomeValues
Mild cytokine release syndromeTherapy well toleratedIM19 4 events

Original publication

Heterogeneous responses of IM19 anti-CD19 CAR T-cell therapy in refractory systemic lupus erythematosus: an open-label pilot study and a mini-review. Ann Rheum Dis. Published 5 February 2026. doi:10.1016/j.ard.2025.12.014

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