B cell Maturation Antigen Targeted Chimeric Antigen Receptor T Cell Therapy for Refractory Systemic Lupus Erythematosus and Systemic Sclerosis.
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Kfir-Erenfeld Shlomit, Elias Shlomo, Asherie Nathalie, Chen Hadass Pri, Karger Elena, Assayag Miri, Bohbot Emilie, Elmikawy Rim, Shaheen Alaa, Bazbaz Ahmad, Friedman-Korn Tal, Molho-Pessach Vered, Vaknin Ada, Grisariu Sigal, Avni Batia, Zimran Eran, Zalcman Nomi, Shehadeh Alaa, Ishtay Aseel, Dubnikob Tatyana, Regev Shelly, Alexander-Shani Rivka, Schlossberg Miriam, Herr Shlomit, Ben-Shahan Stephanie, Zorde-Khevalevsky Elina, Krizhevskaya Marina, Paran Daphna, Ravkaie Lior, Cohen Cyrille J, Peleg Hagit, Mevorach Dror, Stepensky Polina, Gur Chamutal
Аннотация
METHODS: We conducted an ongoing phase 1 trial of HBI0101 in six patients with severe systemic lupus erythematosus (n = 3) or systemic sclerosis (n = 3). The median age was 41 years (range: 21-65), the median disease duration was 2.7 years (range: 1.1-20.5), and patients had received a median of 3.5 previous lines of immunomodulatory therapy (range: 2-9). The median follow-up was six months (range: 6-9).
RESULTS: Grade 3 to 4 neutropenia occurred in two patients and was managed with supportive care. Three patients had hypogammaglobulinemia requiring intravenous immunoglobulin replacement. Cytokine release syndrome occurred in five patients (grade 2 in three and grade 1 in two) and was absent in one patient. No immune effector cell-associated neurotoxicity syndrome was observed. In systemic lupus erythematosus, the Systemic Lupus Erythematosus Disease Activity Index 2000 decreased to 0 in two patients and to 4 in one patient. In systemic sclerosis, skin involvement improved in all three patients with reductions in modified Rodnan skin score and European Scleroderma Trials and Research activity indices.
CONCLUSION: HBI0101 demonstrated an acceptable safety profile and early clinical activity in patients with severe refractory systemic lupus erythematosus or systemic sclerosis, supporting further prospective evaluation.