Lupus & antiphospholipid syndrome
B cell Maturation Antigen Targeted Chimeric Antigen Receptor T Cell Therapy for Refractory Systemic Lupus Erythematosus and Systemic Sclerosis
Authors' conclusion
HBI0101 demonstrated an acceptable safety profile and early clinical activity in patients with severe refractory systemic lupus erythematosus or systemic sclerosis
Study context
- Population
- Patients with severe refractory SLE or SSc; median age 41 years (range: 21–65), median disease duration 2.7 years (range: 1.1–20.5), median 3.5 previous lines of immunomodulatory therapy (range: 2–9)median follow-up six months
- Participants
- 6 patients
- Comparison
- SLE vs SSc
- SLEn = 3
- SScn = 3
- Outcome
- Safety and preliminary efficacy of HBI0101
Methodological detailsongoing
- Ongoing
Main finding
As reported in the abstract
Safety and preliminary efficacy
- SLE: SLEDAI-2K decreased to 0
- 2 patients
- SLE: SLEDAI-2K decreased to 4
- 1 patient
- SSc: skin involvement improved, with reductions in mRSS and EUSTAR activity indices
- all three patients
Safety
Grade 3 to 4 neutropenia
- Patients with grade 3–4 neutropenia (managed with supportive care)
- 2
Hypogammaglobulinemia requiring IV immunoglobulin replacement
- Patients
- 3
Cytokine release syndrome
- Patients with CRS
- 5
- Grade 2
- 3
- Grade 1
- 2
- Absent
- 1
Immune effector cell-associated neurotoxicity syndrome
- None observed
- 0
Original publication
B cell Maturation Antigen Targeted Chimeric Antigen Receptor T Cell Therapy for Refractory Systemic Lupus Erythematosus and Systemic Sclerosis. Arthritis Rheumatol. Published 7 May 2026. doi:10.
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