Lupus & antiphospholipid syndrome
BCMA-CD19 compound CAR T cells for systemic lupus erythematosus: a phase 1 open-label clinical trial
Authors' conclusion
Data suggest that cCAR therapy was safe and effective in inducing MFR and depleting disease-causing autoantibodies in patients with SLE.
Study context
- Population
- Patients with systemic lupus erythematosus (SLE) with biopsy-confirmed (classes III–V) lupus nephritis (LN) and autoantibodiesP1–P13
- Outcome
- Safety and toxicity
Methodological detailssingle-arm, open-label, multicentre, P11 had insufficient lymphocyte counts and was underdosed as compassionate use
- Single-arm
- Open-label
- Multicentre
- P11 had insufficient lymphocyte counts and was underdosed as compassionate use
Main finding
As reported in the abstract
- cCAR T therapy was well tolerant with mild cytokine-release syndrome
Further findings
| Outcome | Values |
|---|---|
| Mean SLEDAI-2K · 3 months | cCAR mean 2.7 · baseline 10.6 |
| Renal function in LN patients · ≤90 days | cCAR 10 events |
Autoantibodies, complement and remission (P3-P13, excluding P11) · 3 months
- Negative for all autoantibodies, complement returned to normal; symptom and medication-free remission (MFR) with follow-up to 46 months
B cell recovery
- Complete recovery of B cells 2-6 months post-cCAR
Renal function in LN patients · ≤90 days
- Renal function significantly improved
P1 and P2 remission
- Symptom and MFR from SLE and complete remission from lymphoma
Safety
- Mild cytokine-release syndrome; well tolerated
Original publication
BCMA-CD19 compound CAR T cells for systemic lupus erythematosus: a phase 1 open-label clinical trial. Ann Rheum Dis. Published 30 September 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →