Lupus & antiphospholipid syndrome
CD19 Chimeric Antigen Receptor (CAR) T-Cell Therapy in Autoimmune Disease — A Case Series with Follow-up
Authors' conclusion
In this case series, CD19 CAR T-cell transfer appeared to be feasible, safe, and efficacious in three different autoimmune diseases
Study context
- Population
- Patients with severe systemic lupus erythematosus (SLE), idiopathic inflammatory myositis or systemic sclerosis receiving a single infusion of CD19 CAR T cells after fludarabine and cyclophosphamide preconditioning
- Participants
- 15 patients
- Exposure
- SLE vs Idiopathic inflammatory myositis vs Systemic sclerosis
- SLEn = 8
- Idiopathic inflammatory myositisn = 3
- Systemic sclerosisn = 4
- Outcome
- Efficacy up to 2 years after CAR T-cell infusion
- Follow-up
- Median 15 months (range, 4 to 29)
Methodological detailssingle infusion, follow-up up to 2 years
- Single infusion
- Follow-up up to 2 years
Main finding
As reported in the abstract
- SLE: all patients had Definition of Remission in SLE (DORIS) remission
- Idiopathic inflammatory myositis: all patients had an American College of Rheumatology-European League against Rheumatism (ACR-EULAR) major clinical response
- Systemic sclerosis: all patients had a decrease in EUSTAR activity index score
- Immunosuppressive therapy completely stopped in all patients
Observational data: associations, not effects.
Further findings
- Mean (±SD) duration of B-cell aplasia, days
- 112±47
Safety
Grade 1 cytokine release syndrome
- Patients with grade 1 cytokine release syndrome
- 10
Grade 2 cytokine release syndrome; grade 1 immune effector cell-associated neurotoxicity syndrome; pneumonia resulting in hospitalisation
- One patient each
- 1
Original publication
CD19 CAR T-Cell Therapy in Autoimmune Disease — A Case Series with Follow-up. N Engl J Med. Published 22 February 2024. doi:10. 1056/ nejmoa2308917
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