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Tests treatment safety and results for SLE (Systemic Lupus)
Official title A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease
ClinicalTrials.gov ID: NCT06925542
What this study is testing
What is CTX112?
CTX112 is an investigational medicine, being studied as a potential treatment for sle (systemic lupus).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age ≥18 years and \< 70 years of age.
- people 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.
- people 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.
You likely can't join if
- Prior anti-CD19 therapy or any gene therapy/genetically modified cell therapy.
- Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant.
- 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...
- Mixed connective tissue disease with no clear predominant disease.
- Presence of study disease manifestations or other conditions that are likely to pose increase safety risks and/or confound disease assessments, or...
See the full eligibility criteria
- Age ≥18 years and \< 70 years of age.
- people 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.
- people 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) people: \- Diagnosis of SLE by a board-certified rheumatologist...
- Prior anti-CD19 therapy or any gene therapy/genetically modified cell therapy.
- Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant.
- 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.
- 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.
- 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.
- Pregnant or lactating.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Redwood City, California, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- New Orleans, Louisiana, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Chapel Hill, North Carolina, United States
- Augsburg, Germany
- Cologne, Germany
- Hanover, Germany
- Mainz, Germany
- Córdoba, Spain
- Pamplona, Spain
- Seville, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Redwood City, California, United States; Chicago, Illinois, United States; Iowa City, Iowa, United States; New Orleans, Louisiana, United States; Boston, Massachusetts, United States; St Louis, Missouri, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.