A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune
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).
| Condition(s) | SLE (Systemic Lupus), Lupus Erythematosus, Systemic, Lupus Nephritis, Systemic Sclerosis, Inflammatory Myopathy, Idiopathic, Myositis, Diffuse Cutaneous Systemic Sclerosis |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | 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). |
| Who can participate | Key Inclusion Criteria: 1. Age ≥18 years and \< 70 years of age. 2. Subjects must voluntarily sign a written informed consent and be willing and able to comply with all study requirements. 3. Adequate hematologic, renal, liver, cardiac and pulmonary organ function. 4. Subjects must agree to use acceptable methods of contraception. 5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, contraceptive guidelines, and other study procedures. 6. Diagnosis of systemic lupus erythematosus (SLE), systemic sclerosis (SSc) or idiopathic inflammatory myopathy (IIM). For systemic lupus erythematosus (SLE) subjects: \- Diagnosis of SLE by a board-certified rheumatologist that conforms with 2019 ACR/EULAR criteria. For lupus nephritis subjects, active, biopsy-proven proli |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | CRISPR Therapeutics |
| Locations | Redwood City, California, United States; Chicago, Illinois, United States; Iowa City, Iowa, United States; Boston, Massachusetts, United States; St Louis, Missouri, United States; Chapel Hill, North Carolina, United States (+2 more sites) |
| Start date | 2025-03-10 |
| NCT ID | NCT06925542 |
| Official listing | https://clinicaltrials.gov/study/NCT06925542 |