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Monoclonal Antibodies

SC291 for Autoimmune Diseases (GLEAM Trial)

Phase 1
Recruiting
Research Sponsored by Sana Biotechnology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called SC291 to see if it is safe and well-tolerated in people with severe autoimmune diseases. The study will also look at how the drug affects the body

Who is the study for?
This trial is for adults aged 18-75 with severe autoimmune diseases like Wegener's Granulomatosis, Lupus, and Vasculitis. Participants must have a specific diagnosis based on EULAR/ACR criteria and not responded to at least two prior treatments. People with CNS lupus manifestations, anti-phospholipid antibody syndrome, or previous CD19-directed cell therapy are excluded.
What is being tested?
The study is testing SC291's safety and effectiveness in treating severe refractory B-cell mediated autoimmune diseases. It will look at how the body responds to the drug, its side effects, and any signs of improvement in disease symptoms.
What are the potential side effects?
While specific side effects of SC291 are not listed here as it's an early-phase trial assessing safety and tolerability, common side effects may include reactions at the injection site, fatigue, headache, nausea or potential immune system-related responses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate safety and tolerability of SC291
Secondary study objectives
Evaluate cellular kinetics and persistence of SC291
Evaluate preliminary clinical response to SC291
Evaluate preliminary clinical response to SC291 (AAV Cohort)
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: LN CohortExperimental Treatment1 Intervention
SC291 with lymphodepleting therapy
Group II: ERL CohortExperimental Treatment1 Intervention
SC291 with lymphodepleting therapy
Group III: AAV CohortExperimental Treatment1 Intervention
SC291 with lymphodepleting therapy

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Who is running the clinical trial?

Sana BiotechnologyLead Sponsor
3 Previous Clinical Trials
94 Total Patients Enrolled
Paul BrunettaStudy DirectorSana Biotechnology, Inc.
~24 spots leftby Dec 2027
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