Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)
NCT06294236 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2025-11-25
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.
Conditions
- Lupus Erythematosus
- Systemic Lupus Erythematosus
- SLE (Systemic Lupus)
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Granulomatous Polyangiitis
- Microscopic Polyangiitis
Interventions
- BIOLOGICAL
-
SC291
SC291 is an allogeneic CAR T cell therapy
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Kristen Lee · Sana Biotechnology, Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-29
- Primary Completion
- 2027-12-31
- Completion
- 2028-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Rituximab in the Treatment of Patients With Bullous Pemphigoid
NCT00286325 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Long-term Safety Study of Infliximab (Remicade)
NCT00261976 ·Status: COMPLETED
-
A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy
NCT06821542 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease
NCT06388564 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256)
NCT07124078 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of PRN1008 in Adult Patients With Pemphigus Vulgaris
NCT02704429 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Gene Therapy Using a Lentiviral Vector to Treat X-linked Chronic Granulomatous Disease
NCT02234934 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease
NCT06263478 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection Using an Autoinjector in Healthy Study Participants
NCT05292131 ·Status: COMPLETED ·Phase: PHASE1
-
Rituximab for ANCA-associated Vasculitis (RAVE) Long-Term Follow-Up Study
NCT01586858 ·Status: TERMINATED
-
Rituximab for the Otolaryngologic Manifestations of Granulomatosis With Polyangiitis
NCT02626845 ·Status: TERMINATED ·Phase: PHASE4
-
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus
NCT05593445 ·Status: COMPLETED ·Phase: PHASE2
-
A Single-arm Phase 2 Prospective Clinical Study of Enatumab in the Treatment of Relapsed/Refractory Warm Antibody Autoimmune Hemolytic Anemia
NCT07190261 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
An Open Label Pilot Study Examining the Use of Rituximab in Patients With Wegener's Granulomatosis Who Have Experienced Disease Relapse on Standard Therapies
NCT00072592 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of Belimumab in Subjects With Primary Sjögren's Syndrome
NCT01160666 ·Status: COMPLETED ·Phase: PHASE2
-
Phenotypic and Functional Characterisation of Human B-cell Response in Pemphigus
NCT04117529 ·Status: UNKNOWN ·Phase: NA
-
A Study to Investigate the Long-term Safety and Efficacy of Belimumab in Adults With Interstitial Lung Disease (ILD) Associated With Systemic Sclerosis (SSc) and Other Connective Tissue Diseases (CTD) (BLISSconneCTD-OLE)
NCT06716606 ·Status: RECRUITING ·Phase: PHASE3
-
Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Healthy Adult Subjects
NCT03794180 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Giant Cell Arteritis
NCT00076726 ·Status: TERMINATED ·Phase: PHASE2
-
Golimumab for the Treatment of Refractory Behcet's Uveitis
NCT04218565 ·Status: TERMINATED ·Phase: PHASE2
-
Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID
NCT02810444 ·Status: COMPLETED ·Phase: PHASE3
-
Safety of Belimumab in People With Idiopathic CD4 Lymphopenia and Autoantibodies (Phoebe)
NCT04097561 ·Status: RECRUITING ·Phase: PHASE1
-
A 24-month Real Life PErsistence Efficacy and Safety Study in IBD Patients in REMission Switched From Intravenous Infliximab to Subcutaneous Infliximab CT-P13 Remsima®SC
NCT04990258 ·Status: ACTIVE_NOT_RECRUITING
-
Randomized Clinical Trial Comparing the Safety and Efficacy of Rituximab Versus Oral Cyclophosphamide in Severe Forms of Mucous Membrane Pemphigoid
NCT03295383 ·Status: RECRUITING ·Phase: PHASE3
-
Belimumab for Prevention of Chronic Graft-versus-Host Disease Following Allogeneic Hematopoietic Cell Transplantation
NCT03207958 ·Status: COMPLETED ·Phase: PHASE1