A Phase 1 interventional study of SC291 in Lupus Erythematosus, Systemic Lupus Erythematosus and SLE (Systemic Lupus), sponsored by Sana Biotechnology. Active, not recruiting at 5 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by Sana Biotechnology · Phase 1, Interventional, and Treatment
SC291-102 is a Phase 1 study to evaluate SC291 safety and tolerability, preliminary clinical response, cellular kinetics and exploratory assessments for subjects with severe autoimmune diseases.
Systemic lupus erythematosus (SLE) is an autoimmune disease with multisystemic organ involvement that is often fatal. SLE is subcategorized as extrarenal lupus (ERL) or lupus nephritis (LN). B cell depletion therapies have played an important role in the treatment of multiple B cell-driven autoimmune diseases.
Subjects included in this trial will be subjects with diagnoses of systemic lupus erythematosus (SLE) including lupus nephritis (LN) and extrarenal systemic lupus erythematosus (ERL), or anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) (including Granulomatous Polyangitis and Microscopic Polyangiitis) who have refractory disease, have relapsed and have not shown appropriate clinical responses following prior systemic treatments.
This study is being conducted to evaluate the safety and efficacy of an investigational cell therapy, SC291, that can be given to patients with LN, ERL or AAV, in separate parallel cohorts, who have active disease.
A single dose of SC291 will be evaluated in patients who are pretreated with a standard regimen including cyclophosphamide (CY) and fludarabine (FLU).
For LN cohort:
For ERL cohort:
Exclusion Criteria:
SC291 with lymphodepleting therapy
Biological: SC291
SC291 with lymphodepleting therapy
Biological: SC291
SC291 with lymphodepleting therapy
Biological: SC291
SC291 is an allogeneic CAR T cell therapy
Also known as: Cyclophosphamide, Fludarabine
Evaluate safety and tolerability of SC291
Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities
Time frame: 24 months
Evaluate preliminary clinical response to SC291
Change from baseline in renal function as measured by Estimated Glomerular Filtration Rate (eGFR) (calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation)
Time frame: 12 months
Evaluate preliminary clinical response to SC291
Change from baseline in proteinuria as measured by Urine Protein Creatinine Ratio (UPCR)
Time frame: 12 months
Evaluate preliminary clinical response to SC291
Duration of drug free remission
Time frame: 12 months
Evaluate preliminary clinical response to SC291
Time to relapse
Time frame: 12 months
Evaluate preliminary clinical response to SC291 (LN and ERL Cohorts)
Change from baseline of Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Time frame: 12 months
Evaluate preliminary clinical response to SC291 (LN Cohort)
Change in disease activity as measured by proportion of subjects achieving complete renal response or partial renal response
Time frame: 12 months
Evaluate preliminary clinical response to SC291 (ERL Cohort)
Change in disease activity as measured by proportion of subjects achieving modified Definitions Of Remission In Systemic Lupus Erythematosus (DORIS) remission
Time frame: 12 months
Evaluate preliminary clinical response to SC291 (AAV Cohort)
Change in disease activity as measured by proportion of subjects achieving remission (Birmingham Vasculitis Activity Score version 3 \[BVAS v3\] of 0)
Time frame: 12 months
Evaluate preliminary clinical response to SC291 (AAV Cohort)
Change in disease activity as measured by change from baseline in BVAS v3
Time frame: 12 months
Evaluate cellular kinetics and persistence of SC291
Levels of SC291 CAR+ T cells in the blood
Time frame: 24 months
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Lupus Erythematosus, Systemic→