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New treatment option for Systemic Lupus Erythematosus (SLE)
Official title CT1190B in the Treatment of Patients With Moderate to Severe Refractory Systemic Lupus Erythematosus (SLE) or Refractory/Progressive Systemic Sclerosis (SSc)
ClinicalTrials.gov ID: NCT06822881
What this study is testing
What is CAR-T Therapy?
CAR-T Therapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for systemic lupus erythematosus (sle).
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
- A Clinical Study Exploring CT1190B in the treatment of patients with moderate to severe refractory systemic lupus erythematosus (SLE) or refractory/progressive systemic sclerosis (SSc)
- 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 60
You may be able to join if
- Voluntary signing of the Informed Consent Form (ICF)
- Age range: At the time of signing the ICF, the age is between 18 and 60 years old (including 18 and 60 years old), regardless of gender.
- No systemic active infection within 2 weeks before screening.
- Contraceptive requirements for participants with child - bearing potential.
- Negative pregnancy test for women with child - bearing potential. for SLE
You likely can't join if
- Previous history of CAR-T cell or other genetically modified T-cell therapies, or previous major organ transplantation.
- Use of B-cell targeted drugs (such as rituximab) within 2 months before screening.
- Allergy or intolerance to lymphodepletion drugs, tocilizumab, or life-threatening allergic reactions, hypersensitivity reactions, or intolerance to...
- Use of corticosteroids ≥ 10 mg/day of prednisone (or equivalent drug) within 10 days before the infusion of CT1190B.
- Use of immunosuppressive agents that affect T-cells (mycophenolate mofetil, methotrexate, cyclosporine, azathioprine, leflunomide, tacrolimus) within...
- Use of JAK inhibitors (tofacitinib, baricitinib tablets, ruxolitinib, etc.) within 3 days before the infusion of CT1190B.
See the full eligibility criteria
Who can join
- Voluntary signing of the Informed Consent Form (ICF)
- Age range: At the time of signing the ICF, the age is between 18 and 60 years old (including 18 and 60 years old), regardless of gender.
- No systemic active infection within 2 weeks before screening.
- Contraceptive requirements for participants with child - bearing potential.
- Negative pregnancy test for women with child - bearing potential. for SLE
- Meet the EULAR/ACR 2019 SLE classification criteria with a disease history ≥ 6 months.
- Treatment and disease activity requirements: o Before screening, the participant must have received treatment with glucocorticoids combined with immunosuppressive agents (including cyclophosphamide, mycophenolate...
- Positive antibody test at screening: Positive antinuclear antibody, and/or positive anti-ds-DNA antibody, and/or positive anti-Smith antibody.
- Disease activity score or organ damage: At the screening stage, the SLEDAI - 2K score is ≥ 7 points
- Active organ involvement at screening: isolated skin and mucous membrane involvement is not eligible for inclusion.
- Adequate organ function: o Renal function: Defined as a calculated creatinine clearance rate (Cockcroft - Gault) ≥ 50 mL/min without the need for hydration assistance. o Bone marrow function: Defined as absolute...
- Cardiac function: Defined as a left ventricular ejection fraction (LVEF) ≥ 40% as evaluated by echocardiogram (ECHO) within 8 weeks before screening. for SSc
- Meet the 2013 EULAR/ACR classification criteria for systemic sclerosis and the diffuse - type manifestation simultaneously.
- Combined with interstitial pneumonia caused by SSc.
- Meet the definition of refractory or progressive disease: o Refractory disease definition: Ineffective after more than 6 months of conventional treatment, or disease recurrence after remission. Conventional treatment is...
- Progressive disease definition (in the past 6 months):
- Skin progression: An increase in mRSS \> 10%.
- Lung disease progression: A 10% decrease in FVC, or a 5% decrease in FVC accompanied by a 15% decrease in DLCO.
- Important organ function: o Renal function: Defined as a calculated creatinine clearance rate (Cockcroft - Gault) ≥ 50 mL/min without the need for hydration assistance. o Bone marrow function: Defined as absolute...
What rules you out
- Previous history of CAR-T cell or other genetically modified T-cell therapies, or previous major organ transplantation.
- Use of B-cell targeted drugs (such as rituximab) within 2 months before screening.
- Allergy or intolerance to lymphodepletion drugs, tocilizumab, or life-threatening allergic reactions, hypersensitivity reactions, or intolerance to the CT1190B preparation or its excipients, or a history of other severe...
- Use of corticosteroids ≥ 10 mg/day of prednisone (or equivalent drug) within 10 days before the infusion of CT1190B.
- Use of immunosuppressive agents that affect T-cells (mycophenolate mofetil, methotrexate, cyclosporine, azathioprine, leflunomide, tacrolimus) within 10 days before the infusion of CT1190B.
- Use of JAK inhibitors (tofacitinib, baricitinib tablets, ruxolitinib, etc.) within 3 days before the infusion of CT1190B.
- Vaccination with live-attenuated vaccines, inactivated vaccines, or RNA vaccines within 1 month before screening.
- Diagnosis of cancer within 2 years before signing the ICF. Exceptions include non-melanoma skin cancer treated by radical therapy, local prostate cancer, biopsy-proven cervical carcinoma in situ or squamous...
- Undergoing major surgery within 4 weeks before signing the ICF, or planning to undergo major surgery during the study, and the investigator deems it will pose an unacceptable risk to the participant.
- Positive test for HIV, syphilis, active hepatitis B virus infection, or active hepatitis C virus infection at screening.
- History of central nervous system diseases before screening, including but not limited to cerebrovascular accident, encephalitis, epilepsy, convulsions/seizures, stroke, severe brain injury, dementia, Parkinson's...
- History of any of the following cardiovascular diseases within 1 month before screening: Heart failure of class III or IV as defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina...
- Participation in other clinical studies within 3 months before screening or still within five half-lives after the last dose of the drug.
- Current presence of any uncontrolled active infection, including but not limited to active tuberculosis, etc.
- History or evidence of suicidal thoughts within 6 months before signing the ICF, or any suicidal behavior within the previous 12 months, and the investigator deems there is a significant suicide risk.
- Pregnant or breastfeeding women.
- Poor compliance judged by the investigator, inability or unwillingness to comply with the requirements of the study protocol, or other reasons that make the participant unsuitable for this clinical study. Exclusion...
- Severe lupus nephritis within 2 months before screening, requiring hemodialysis, or receiving prednisone ≥ 100 mg/d or equivalent corticosteroid treatment for ≥ 14 days.
- Lupus crisis within 1 month before screening, and the investigator deems it inappropriate for the participant to participate in this study.
- Central nervous system manifestations caused by lupus before screening, including but not limited to lupus headache, seizures, cognitive impairment, impaired intellectual function, visual impairment, etc.
- History of ≥ grade 2 bleeding within 30 days before screening.
- Plasmapheresis, plasma separation, or hemodialysis within 14 days before screening. Exclusion Criteria for SSc 1\. FVC ≤ 30% of the predicted value or DLCO (corrected for hemoglobin) ≤ 30% of the predicted value. 2\...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
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 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. 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.