Actively Recruiting
A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease
Led by CRISPR Therapeutics · Updated on 2025-12-17
80
Participants Needed
8
Research Sites
355 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-arm, open-label, multicenter, ascending dose Phase 1 study evaluating the safety and preliminary efficacy of CTX112 in adult subjects with refractory autoimmune diseases, including active systemic lupus erythematosus (SLE), systemic sclerosis (SSc), or idiopathic inflammatory myopathy (IIM).
CONDITIONS
Official Title
A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and under 70 years.
- Voluntarily sign informed consent and comply with study requirements.
- Adequate blood, kidney, liver, heart, and lung function.
- Agree to use acceptable contraception methods.
- Willing and able to follow scheduled visits, treatment plans, lab tests, and study procedures.
- Diagnosis of systemic lupus erythematosus (SLE), systemic sclerosis (SSc), or idiopathic inflammatory myopathy (IIM).
- For SLE: Diagnosis by a board-certified rheumatologist meeting 2019 ACR/EULAR criteria; lupus nephritis subjects must have active, biopsy-proven proliferative lupus nephritis Class III or IV with or without Class V and appropriate NIH activity score per 2018 criteria.
- For SSc: Diagnosis of diffuse cutaneous systemic sclerosis or SSc-ILD meeting 2013 ACR/EULAR criteria with active skin or lung disease.
- For IIM: Diagnosis of dermatomyositis, polymyositis, or myositis as part of rheumatologic overlap syndrome, antisynthetase syndrome, or immune-mediated necrotizing myopathy meeting 2017 ACR/EULAR criteria with moderate to severe skin or lung involvement.
You will not qualify if you...
- Prior anti-CD19 or gene-modified cell therapy.
- Prior solid organ or hematopoietic cell transplant.
- Severe active or history of central nervous system involvement.
- History of seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or other autoimmune CNS disease except SLE, SSc, or IIM.
- Mixed connective tissue disease without clear predominant disease.
- Conditions likely to increase safety risks or confound assessments for CAR T cell therapy.
- History of primary or secondary immunodeficiency.
- History or presence of certain bacterial, viral, or fungal infections.
- Cancer in last 5 years except low recurrence risk cancers.
- Genetic disorders linked to bone marrow failure or myelodysplastic syndrome.
- History or current catastrophic or ongoing anticoagulation-requiring antiphospholipid syndrome.
- Pregnant or lactating.
- Diseases or treatments incompatible with the study protocol.
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Research Site 4
Redwood City, California, United States, 94063
Actively Recruiting
2
Research Site 2
Chicago, Illinois, United States, 63110
Actively Recruiting
3
Research Site 8
Iowa City, Iowa, United States, 52242
Actively Recruiting
4
Research Site 6
Boston, Massachusetts, United States, 02118
Actively Recruiting
5
Research Site 1
St Louis, Missouri, United States, 63130
Actively Recruiting
6
Research Site 5
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
7
Research Site 7
Augsburg, Germany, 86156
Not Yet Recruiting
8
Research Site 3
Hanover, Germany, 30625
Actively Recruiting
Research Team
C
Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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