Trials / Active Not Recruiting
Active Not RecruitingNCT06294236
Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)
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)
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 7 (estimated)
- Sponsor
- Sana Biotechnology · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
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).
Conditions
- Lupus Erythematosus
- Systemic Lupus Erythematosus
- SLE (Systemic Lupus)
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Granulomatous Polyangiitis
- Microscopic Polyangiitis
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SC291 | SC291 is an allogeneic CAR T cell therapy |
Timeline
- Start date
- 2024-04-29
- Primary completion
- 2027-12-01
- Completion
- 2028-03-01
- First posted
- 2024-03-05
- Last updated
- 2025-11-25
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06294236. Inclusion in this directory is not an endorsement.