Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06294236
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-02-12
Brief Title:
Study Evaluating SC291 in Subjects With Severe rr B-cell Mediated Autoimmune Diseases GLEAM
Sponsor:
Sana Biotechnology
Organization:
Sana Biotechnology
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None