A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Subjects with Active Systemic Lupus Erythematosus

Active Systemic Lupus Erythematosus;Systemic lupus erythematosus (SLE) is a chronic autoimmune disorder characterized by autoantibody production and abnormal B cell function. SLE presents with fluctuating severity and may cause tissue damage in a variety of organs over time. Lupus nephritis (LN) is a common severe manifestation of SLE, which can lead to significant morbidity and mortality.

AEs occurring within 28 days after CABA-201 infusion, including DLTs and AEs related to CABA-201.

AEs, vital signs, physical examination, and clinical laboratory tests occurring within 156 weeks after CABA-201 infusion., Changes from baselinea in WBC with differential, including B cell counts., Frequency of reaching released product at target dose., Fold cell expansion, transduction efficiency, vector copy number per cell, and product phenotype; Total number of CABA-201-positive cells in each manufacturing run; Percent of CAR-transduced cells in the total number of cells for infusion., Number and percentage of CABA-201-positive cells in the peripheral blood of subjects over time., Changes from baseline in anti-dsDNA antibodies, C3, C4, and CH50., Changes in UPCR, eGFR, SLEDAI-2K score, BILAG-2004 score, PGA score, joint counts, CLASI score, and SDI.; Proportions of subjects achieving complete renal response (for LN cohort only), SRI-4, BICLA responses, and LLDAS and DORIS criteria., Time to achieve complete renal response (for LN cohort only), SRI-4, SRI-5, SRI-6, BICLA responses, LLDAS, and DORIS remission., Change from baseline in the dose of concomitant corticosteroids and other SLE-related therapies.; Proportion of subjects achieving a dose of ≤5 mg/day oral prednisone or equivalent.; Proportion of subjects who require no SLE-related therapies., Changes from baselinea in SF-36v2, pain NRS, FACIT-F, PtGA, Lupus QoL, and EQ-5D-5L scores., Incidences of mild/moderate and severe disease flare per BILAG-2004 and SFI.; Time to mild/moderate and severe disease flare., Proportions of subjects achieving drug free complete renal response (for LN cohort only), SRI-4, BICLA responses, LLDAS, and DORIS remissions., Time to achievement of drug-free complete renal response (for LN cohort only), SRI-4, BICLA responses, LLDAS and DORIS remission.

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