A Phase 2, adaptive, randomized, open-label, assessor-blinded active-controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus Standard of Care in patients suffering from systemic lupus erythematosus (SLE) with active, refractory lupus nephritis (LN).

systemic lupus erythematosus (SLE) with active, refractory lupus nephritis (LN)

Proportion of participants with clinical response at Week 52, defined as meeting the Definition Of Remission In Systemic Lupus Erythematosus (DORIS) AND maintaining treatment with low dose glucocorticoids., Proportion of participants achieving clinical response at Week 52. Clinical response is defined as for xxx

Proportion of participants achieving complete renal response (CRR) at Week 52, Number of weeks where Lupus Low Disease Activity Score (LLDAS) was achieved from Week 12 until Week 52, Proportion of participants without flaring (i.e., 1 new BILAG2004 A or 2 new BILAG2004 B flares) from Week 12 through Week 52, Annualized cumulative corticosteroids dose until Week 52, Proportion of participants who are negative (i.e., titer within normal limits) for antinuclear antibodies (ANA), anti-dsDNA, and anti-Sm at Week 52, FACIT-Fatigue score change from baseline at Week 52, Proportion of participants who were in Sustained Remission at Week 52 to Week 76, Safety parameters including vital signs, adverse events, laboratory parameters and ECG evaluation, Proportion of participants upon enrollment achieving complete renal response (CRR) at Week 52, Number of weeks where Lupus Low Disease Activity Score (LLDAS) was achieved from XXX until Week 52, Proportion of participants without flaring (i.e., 1 new BILAG2004 A or 2 new BILAG2004 B flares) from xxx through Week 52, Annualized cumulative corticosteroids dose until Week 52, Proportion of participants who are negative (i.e., titer within normal limits) for antinuclear antibodies (ANA), anti-dsDNA, and anti-Sm at Week 52, FACIT-Fatigue score change from baseline at Week 52, Proportion of participants who were in Sustained Remission at Week 52 to Week 76, Safety parameters include vital signs, adverse events, laboratory parameters and ECG evaluation

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