A Phase 1 Dose Evaluation Study of the Safety and Preliminary Efficacy of Anti-CD19 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX112) in Adult Subjects With Refractory Autoimmune Disease

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Age ≥18 years and \< 70 years of age.

• Subjects must voluntarily sign a written informed consent and be willing and able to comply with all study requirements.

• Adequate hematologic, renal, liver, cardiac and pulmonary organ function.

• Subjects must agree to use acceptable methods of contraception.

• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, contraceptive guidelines, and other study procedures.

• 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 proliferative lupus nephritis Class III or IV, either with or without the presence of Class V, and appropriate National Institutes of Health index activity score using the 2018 International Society of Nephrology/Renal Pathology Society criteria.

⁃ For Systemic Sclerosis (SSc) subjects:

⁃ \- Diagnosis of diffuse cutaneous systemic sclerosis (dcSSC) or SSc-ILD that conforms with 2013 ACR/EULAR criteria. Subjects should meet active skin or lung disease criteria.

⁃ For Idiopathic Inflammatory Myopathy (IIM) subjects:

⁃ \- Diagnosis with dermatomyositis (DM), polymyositis (PM) or myositis as part of rheumatologic overlap syndrome, antisynthetase (ASyS), or immune-mediated necrotizing myopathy (IMNM) that conforms with 2017 ACR/EULAR criteria for inflammatory myopathies. Subjects must meet moderate severe, skin, or lung involvement criteria.

Locations
United States
California
Research Site 4
RECRUITING
Redwood City
Iowa
Research Site 8
NOT_YET_RECRUITING
Iowa City
Illinois
Research Site 2
RECRUITING
Chicago
Massachusetts
Research Site 6
RECRUITING
Boston
Missouri
Research Site 1
RECRUITING
St Louis
North Carolina
Research Site 5
RECRUITING
Chapel Hill
Other Locations
Germany
Research Site 7
NOT_YET_RECRUITING
Augsburg
Research Site 3
NOT_YET_RECRUITING
Hanover
Contact Information
Primary
Clinical Trials
medicalaffairs@crisprtx.com
1 877-214-4634
Time Frame
Start Date: 2025-03-10
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 80
Treatments
Experimental: CTX112
Administered by IV infusion following lymphodepleting chemotherapy
Sponsors
Leads: CRISPR Therapeutics

This content was sourced from clinicaltrials.gov