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).
1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.
This study's planned enrollment of 7 is below the median of 52 across 876 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Sana Biotechnology is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For LN cohort:
For ERL cohort:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Started Apr 2024 (actual). Primary completion is estimated for Dec 2027, 44 months after the start.
Of 107 industry-sponsored phase 1 interventional studies under Lupus Erythematosus, Systemic, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 35. This study's planned 44 months is above that.
Counting every sponsor, half of 146 studies reached it within 28 months; a quarter within 16 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lupus Erythematosus, Systemic →