Tests CTX112 cell therapy in adults with hard-to-treat autoimmune disease
Tests CTX112, gene-edited immune cells, in adults with lupus, sclerosis or myositis.
Plain-language title generated from the registry record
Registry title: A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease
Key facts
- Where
- Augsburg, Cologne, Hanover, and Mainz, GermanySee the 4 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with lupus, systemic sclerosis or idiopathic inflammatory myopathy (muscle inflammation) that is still active after earlier treatment. It tests a gene-edited T-cell therapy called CTX112.
- Age
- 18 years or older and younger than 70 years.
- Sex
- All sexes can join.
- Disease stage
- Active systemic lupus erythematosus (SLE); for lupus nephritis, biopsy-proven Class III or IV with or without Class V. Or diffuse cutaneous systemic sclerosis or SSc-ILD with active skin or lung disease. Or dermatomyositis, polymyositis, antisynthetase syndrome or immune-mediated necrotizing myopathy with moderate to severe, skin or lung involvement.
- Earlier treatment
- People who had earlier anti-CD19 therapy, or any gene therapy or genetically modified cell therapy, cannot join.
Main reasons for not taking part
- Earlier anti-CD19 therapy or gene or modified cell therapy
- Earlier solid organ or hematopoietic cell transplant
- Severe active or past involvement of the central nervous system
- Cancer in the last 5 years (some low-risk cancers excepted)
- Pregnant or breastfeeding
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06925542, who can take part
Where in Germany
- University of AugsburgAugsburg, GermanyTaking people
- Universitätsklinikum KölnCologne, GermanyTaking people
- Medizinische Hochschule Hannover (MHH)Hanover, GermanyTaking people
- UCT University Medical Center MainzMainz, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- CRISPR Therapeutics
- Trial code
- NCT06925542
- Record updated
- 26 October 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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.
Exclusion: Prior anti-CD19 therapy or any gene therapy/genetically modified cell therapy; Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant; Presence of study disease manifestations or other conditions that are likely to pose increase safety risks and/or confound disease assessments, or pose significant risk to those receiving CAR T cell therapy; Severe active or history of central nervous (CNS) involvement; History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease or any autoimmune disease with CNS involvement other than SLE, SSc or IIM; Mixed connective tissue disease with no clear predominant disease; History of primary or secondary immunodeficiency; Presence or history of certain bacterial, viral or fungal infection; Malignancy in the last 5 years (with the exception of cancers deemed to be low likelihood for recurrence); Diagnosis of a genetic disorder associated with bone marrow failure or myelodysplastic syndrome; History or current diagnosis of catastrophic anti-phospholipid syndrome or anti phospholipid syndrome that requires ongoing anticoagulation; Presence or history of disease requiring treatment that is not compatible with the study protocol; presence or history of other conditions that are not compatible with the study protocol; Pregnant or lactating.