A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease
Part of paid clinical trials in La Jolla, California.
- Sponsor
- CRISPR Therapeutics
- Study ID
- NCT06925542
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Diffuse Cutaneous Systemic Sclerosis
- Inflammatory Myopathy, Idiopathic
- Lupus Erythematosus, Systemic
- Lupus Nephritis
- Myositis
- SLE (Systemic Lupus)
- Systemic Sclerosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- CTX112 — BIOLOGICALCTX112 (CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components)
Study Details
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).
Key Dates
- First listed
- Apr 13, 2025
- Start date
- Mar 10, 2025
- Status verified
- Aug 2026
- Primary completion
- Dec 31, 2031
- Completion
- Dec 31, 2031
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: CTX112Administered by IV infusion following lymphodepleting chemotherapy
Primary Outcome Measure
To evaluate the safety of CTX112 in adult subjects with refractory autoimmune diseases, including SLE, SSc or IIM [ Time Frame: From CTX112 infusion up to 28 days post-infusion ]
Central Contacts
- Clinical Trials1 877-214-4634
Locations (9)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UC San Diego Health | La Jolla | California | 92037 | Brian Pedersen, MD (PRINCIPAL_INVESTIGATOR) |
| Stanford University Medical Center | Redwood City | California | 94063 | Sally Arai, MD Sally Arai, MD (PRINCIPAL_INVESTIGATOR) |
| Northwestern Medicine, Robert H. Lurie Comprehensive Cancer Center | Chicago | Illinois | 63110 | George Georges, MD (PRINCIPAL_INVESTIGATOR) |
| University of Iowa | Iowa City | Iowa | 52242 | Hanna Zembrzuska, MD (PRINCIPAL_INVESTIGATOR) |
| Tulane University Medical Center | New Orleans | Louisiana | 70118 | Anita Dhanrajani, MD Anita Dhanrajani, MD (PRINCIPAL_INVESTIGATOR) |
| Boston Medical Center | Boston | Massachusetts | 02118 | Hanni Menn-Josephy, MD Hanni Menn-Josephy, MD (PRINCIPAL_INVESTIGATOR) |
| Washington University School of Medicine | St Louis | Missouri | 63130 | Alfred Kim, MD (PRINCIPAL_INVESTIGATOR) |
| University of North Carolina TraCS Institute - CTRC | Chapel Hill | North Carolina | 27599 | Saira Sheikh, MD Saira Sheikh, MD (PRINCIPAL_INVESTIGATOR) |
| Oregon Health Sciences University | Portland | Oregon | 97239 | Richard Maziarz, MD (PRINCIPAL_INVESTIGATOR) |
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