RecruitingPhase 1NCT06925542

A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease

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

Sponsor

CRISPR Therapeutics

Enrollment

80 participants

Start Date

Mar 10, 2025

Study Type

INTERVENTIONAL

Conditions

SLE (Systemic Lupus)Diffuse Cutaneous Systemic Sclerosis Systemic Sclerosis Myositis Lupus Erythematosus, Systemic Lupus Nephritis Inflammatory Myopathy, Idiopathic

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called CTX112 for people with diffuse cutaneous systemic sclerosis, inflammatory myopathy, idiopathic, and other related conditions. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALCTX112

CTX112 (CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components)

Locations(14)

Stanford University Medical Center

Redwood City, California, United States

Northwestern Medicine, Robert H. Lurie Comprehensive Cancer Center

Chicago, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

Manning Family Children's Hospital of New Orleans

New Orleans, Louisiana, United States

Boston Medical Center

Boston, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of North Carolina TraCS Institute - CTRC

Chapel Hill, North Carolina, United States

University of Augsburg

Augsburg, Germany

Universitätsklinikum Köln

Cologne, Germany

Medizinische Hochschule Hannover (MHH)

Hanover, Germany

UCT University Medical Center Mainz

Mainz, Germany

Research Site 10

Córdoba, Spain

Research Site 9

Pamplona, Spain

Research Site 11

Seville, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06925542

Related Trials

A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease

NCT0708510414 locations

Wellness & Workforce Solution for Lupus/Lupus Nephritis

NCT062171071 location

Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab.

NCT0733024522 locations

A Research Trial to Assess if Cenerimod is Efficacious and Safe to Treat Active Lupus Nephritis on Top of Regular Treatment

NCT0720112914 locations

Phase 1a/b Tolerability of NTR-1011 in Healthy Adults and Adult Patients With SLE and RA

NCT072376597 locations