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Lupus ErythematosusPhase 1NCT06294236

Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)

A Phase 1 study testing SC291 in people with Lupus Erythematosus and Systemic Lupus Erythematosus, run by Sana Biotechnology at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
SC291
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
5 sitesUnited States
Study dates
29 Apr 2024to Mar 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 and ≤75
  • 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 Society (ISN/RPS) criteria
  • Refractory disease to ≥ 2 prior treatment regimens
  • For ERL cohort:
Show all 9Show fewer
  • Diagnosis of SLE based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for adult SLE
  • Severe or relapsing disease not responding to at least 2 prior recent disease-modifying therapies
  • For AAV Cohort, diagnosed with Granulomatous Polyangiitis (GPA) or Microscopic Polyangiitis (MPA) based on the 2022 ACR/EULAR classification criteria

Who cannot join

  • Prior CD19-directed cell therapy including CAR T treatment or other genetically modified cell therapy (e.g., Natural Killer (NK) cell)
  • For LN and ERL Cohorts, central nervous system (CNS) lupus manifestations or history or presence of CNS disorder
  • For LN and ERL Cohorts, diagnosis of anti-phospholipid antibody syndrome
  • For AAV Cohort only, Diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA) as defined by the 2022 ACR/EULAR classification criteria for EGPA -

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of Colorado

    Aurora, Colorado, 80045

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Swedish Medical Center

    Seattle, Washington, 98122

Other trials in United States

About this study

Official title: A Phase 1 Study Evaluating SC291, a Hypoimmune, Allogeneic CD19-directed CAR T Cell Therapy, in Subjects With Severe Relapsed or Refractory Autoimmune Diseases (GLEAM)

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.

Read the detailed description

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).

Being tested
SC291
Keywords
Autoimmune Disease, Systemic Lupus Erythematosus, Lupus Nephritis, Lupus, Extrarenal Lupus, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Granulomatous Polyangitis, Microscopic Polyangiitis, CAR T Cell Therapy, Allogeneic, Hypoimmune, CD19, Cyclophosphamide, Fludarabine, Cellular Therapy, SC291, ANCA Associated Vasculitis, SLE, ANCA, Vasculitis
Medical subject headings
Lupus Erythematosus, Systemic, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Autoimmune Diseases, Lupus Nephritis, Vasculitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SC291Biological

    Also called Cyclophosphamide, Fludarabine

    SC291 is an allogeneic CAR T cell therapy

Study groups in NCT06294236
Study groupRoleWhat they receive
LN CohortExperimentalSC291 with lymphodepleting therapy
Receives: Biological: SC291
ERL CohortExperimentalSC291 with lymphodepleting therapy
Receives: Biological: SC291
AAV CohortExperimentalSC291 with lymphodepleting therapy
Receives: Biological: SC291

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate safety and tolerability of SC291

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

    Measured: 24 months

Secondary outcomes (10)

  1. 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)

    Measured: 12 months

  2. Evaluate preliminary clinical response to SC291

    Change from baseline in proteinuria as measured by Urine Protein Creatinine Ratio (UPCR)

    Measured: 12 months

  3. Evaluate preliminary clinical response to SC291

    Duration of drug free remission

    Measured: 12 months

  4. Evaluate preliminary clinical response to SC291

    Time to relapse

    Measured: 12 months

  5. Evaluate preliminary clinical response to SC291 (LN and ERL Cohorts)

    Change from baseline of Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)

    Measured: 12 months

  6. 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

    Measured: 12 months

  7. 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

    Measured: 12 months

  8. 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)

    Measured: 12 months

  9. Evaluate preliminary clinical response to SC291 (AAV Cohort)

    Change in disease activity as measured by change from baseline in BVAS v3

    Measured: 12 months

  10. Evaluate cellular kinetics and persistence of SC291

    Levels of SC291 CAR+ T cells in the blood

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2024
  2. Study start29 Apr 2024
  3. Primary completionDec 2027 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
7 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06294236
Sponsor's protocol ID
SC291-102
Status last verified
Nov 2025
First submitted
12 Feb 2024
Last updated
25 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SC291 in people with Lupus Erythematosus and Systemic Lupus Erythematosus, run by Sana Biotechnology at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate safety and tolerability of SC291 (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06294236.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.

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