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SC291

Phase 1

Lupus Erythematosus | Monoclonal antibody | Immunology |Sana Biotechnology, Inc.|Last Updated: Nov 25, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment7

FDA Designations

FAST_TRACK

Clinical trial landscape

SC291 · 2 trials · 8 indications

Phase 1 2
NCT06294236Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)Lupus Erythematosus
ACTIVE NOT_RECRUITING7 Analytics
NCT05878184Study Evaluating SC291 in Subjects With r/r B-cell Malignancies (ARDENT)Non Hodgkin Lymphoma
ACTIVE NOT_RECRUITING16 Analytics
PHASE1ACTIVE NOT_RECRUITING
Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)
Lupus ErythematosusUnlock trial analytics
PHASE1ACTIVE NOT_RECRUITING
Study Evaluating SC291 in Subjects With r/r B-cell Malignancies (ARDENT)
Non Hodgkin LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate safety and tolerability of SC291
24 months

Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities

Secondary Endpoints

Evaluate preliminary clinical response to SC291
12 months
Evaluate preliminary clinical response to SC291 (LN and ERL Cohorts)
12 months
Evaluate preliminary clinical response to SC291 (LN Cohort)
12 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LN CohortEXPERIMENTALSC291 with lymphodepleting therapy
ERL CohortEXPERIMENTALSC291 with lymphodepleting therapy
AAV CohortEXPERIMENTALSC291 with lymphodepleting therapy
SC291 Plus Chemotherapy RegimenEXPERIMENTALA conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with SC291

Interventions

NameTypeDescription
SC291BIOLOGICALSC291 is an allogeneic CAR T cell therapy
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Age ≥18 and ≤75 2. For LN cohort: * Diagnosis of SLE based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) * Biopsy-proven LN class III or IV, according to 2018 Revised International Society of Nephrology/Renal Pathology So...

Countries:United StatesAustralia
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Recent Changes (Last 90 Days)

LOWMay 26, 2026NCT05878184primaryCompletionDate: changed
LOWMay 26, 2026NCT06294236primaryCompletionDate: changed
LOWMay 24, 2026NCT05878184studyFirstPostDate: changed
LOWMay 24, 2026NCT06294236studyFirstPostDate: changed

Frequently asked questions about SC291

What is SC291 used for?

SC291 is an investigational monoclonal antibody being studied for use in lupus erythematosus and non-Hodgkin lymphoma. It is also being evaluated in chronic lymphocytic leukemia and certain B-cell mediated autoimmune diseases, including systemic lupus erythematosus and ANCA-associated vasculitis.

What does SC291 target?

SC291 is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. The drug is being studied in B-cell mediated diseases, suggesting it may affect B cells, but the exact target is not specified.

Who makes SC291?

SC291 is being developed by Sana Biotechnology, Inc., a company traded under the ticker SANA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with certain B-cell malignancies and autoimmune diseases.

What phase is SC291 in?

SC291 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is currently being studied in early-stage trials to assess its safety, tolerability, and preliminary efficacy in humans.

What clinical trials is SC291 in?

SC291 is being evaluated in two Phase 1 trials. NCT05878184, called ARDENT, is studying the drug in patients with relapsed or refractory B-cell malignancies, including non-Hodgkin lymphoma and chronic lymphocytic leukemia. NCT06294236, called GLEAM, is studying it in patients with severe B-cell mediated autoimmune diseases, including lupus erythematosus.

Is SC291 the same as any other drug?

SC291 is not known to have any alternative names. It is a unique investigational drug candidate developed by Sana Biotechnology. No other names or aliases for this drug have been reported in the available information.