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Tests treatment safety and results for Systemic Lupus Erythematosus (SLE)
Official title Safety, Efficacy and Cellular Metabolic Dynamics of ct1192 in Patients With Moderate to Severe Refractory SLE
ClinicalTrials.gov ID: NCT07031713
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 to explore the safety, efficacy and cell metabolic kinetics of universal CD19/20 car-t cell injection in moderate to severe refractory systemic lupus erythematosus. This study is a single arm, open, exploratory dose increasing clinical study, which aims to evaluate the safety, efficacy and cell metabolic dynamics of ct1192 cells in patients with SLE.
- 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
- Meet the EULAR/ACR 2019 SLE classification criteria, with a medical history of ≥ 6 months;
- Voluntarily sign the Informed Consent Form (ICF); When signing the ICF, the age range is between 18 and 60 years old (including 18 and 60 years old)...
- No systemic active infections (such as infectious pneumonia or tuberculosis) within the first 2 weeks of screening;
- Women with fertility (defined as all physiologically capable women) must agree to use effective contraceptive methods from at least 28 days prior to...
- Women with fertility must have a negative serum β - human chorionic gonadotropin (β - hCG) test result within 48 hours prior to screening and...
You likely can't join if
- Patients with severe lupus nephritis within the first 2 months of screening need to undergo hemodialysis or receive prednisone ≥ 100 mg/d or...
- Have undergone plasma exchange, plasma separation, hemodialysis within 30 days prior to screening, or have had lupus crisis within 30 days prior to...
- Individuals with a history of ≥ grade 2 bleeding or requiring long-term anticoagulant therapy within the 30 days prior to screening;
- Screening for a history of any of the following cardiovascular diseases within the previous 30 days: Grade III or IV heart failure defined by the New...
- Prior to screening, central nervous system manifestations caused by lupus, including but not limited to lupus headache, epileptic seizures, cognitive...
- Individuals with central nervous system diseases prior to screening include but are not limited to: cerebrovascular accidents, encephalitis...
See the full eligibility criteria
Who can join
- Meet the EULAR/ACR 2019 SLE classification criteria, with a medical history of ≥ 6 months;
- Voluntarily sign the Informed Consent Form (ICF); When signing the ICF, the age range is between 18 and 60 years old (including 18 and 60 years old), with no gender restrictions;
- No systemic active infections (such as infectious pneumonia or tuberculosis) within the first 2 weeks of screening;
- Women with fertility (defined as all physiologically capable women) must agree to use effective contraceptive methods from at least 28 days prior to the start of vaginal discharge until 1 year after CT1192 infusion. Egg...
- Women with fertility must have a negative serum β - human chorionic gonadotropin (β - hCG) test result within 48 hours prior to screening and gonorrhea treatment.
- Prior to screening, patients must have received a combination of glucocorticoids and immunosuppressants (including cyclophosphamide, mycophenolate mofetil, tacrolimus, methotrexate, cyclosporine, leflunomide) and/or...
- Renal function: defined as a creatinine clearance rate (Cockcroft Gault) calculated without hydration assistance of ≥ 50 mL/min;
- Bone marrow function: defined as neutrophil count (ANC) ≥ 1.0 × 109/L and hemoglobin (Hb) ≥ 60 g/L. Blood transfusions and growth factors must not be used to meet these requirements within 7 days prior to eligibility...
- Liver function: defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 x upper limit of normal (ULN), total bilirubin ≤ 2 x upper limit of normal (ULN)
- Coagulation function: defined as International Normalized Ratio (INR) or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN;
- Pulmonary function: Blood oxygen saturation (SpO2) ≥ 92% in indoor air (measured by pulse oximeter);
- Cardiac function: defined as a left ventricular ejection fraction (LVEF) of ≥ 50% evaluated by echocardiography (ECHO) within the first 8 weeks of screening.
What rules you out
- Patients with severe lupus nephritis within the first 2 months of screening need to undergo hemodialysis or receive prednisone ≥ 100 mg/d or equivalent hormone therapy for ≥ 14 days;
- Have undergone plasma exchange, plasma separation, hemodialysis within 30 days prior to screening, or have had lupus crisis within 30 days prior to screening;
- Individuals with a history of ≥ grade 2 bleeding or requiring long-term anticoagulant therapy within the 30 days prior to screening;
- Screening for a history of any of the following cardiovascular diseases within the previous 30 days: Grade III or IV heart failure defined by the New York Heart Association (NYHA), myocardial infarction, unstable...
- Prior to screening, central nervous system manifestations caused by lupus, including but not limited to lupus headache, epileptic seizures, cognitive impairment, impaired intellectual function, visual impairment, etc;
- Individuals with central nervous system diseases prior to screening include but are not limited to: cerebrovascular accidents, encephalitis, epilepsy, seizures/convulsions, stroke, severe brain injury, dementia...
- No systemic active infections, including but not limited to active tuberculosis, within 2 weeks prior to screening;
- Previously received CAR-T cell or other genetically modified T cell therapy, or have a history of major organ transplantation (such as heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation;
- Allergic or intolerant reactions to Qinglin drugs, tocilizumab, or life-threatening allergic reactions, hypersensitivity reactions, or intolerance to CT1192 preparations or their excipients (including dimethyl sulfoxide...
- Screening for drugs targeting B cells, such as rituximab, that have been used within the previous 6 months;
- Within the 12 weeks prior to screening, other biologics such as taceptil and belimumab have been used for treatment;
- Hormone use ≥ 10 mg/day of prednisone (or equivalent) within 2 weeks prior to CT1192 infusion, with the use of physiological substitutes, topical and inhaled steroids allowed;
- Received immunosuppressive agents that affect T cells (mycophenolate mofetil, methotrexate, cyclosporine, azathioprine, leflunomide, tacrolimus) within 2 weeks prior to CT1192 infusion;
- Have received JAK inhibitors (tofacitinib, baritinib tablets, lukatinib, etc.) within 2 weeks prior to CT1192 infusion;
- Have received attenuated live vaccine, inactivated vaccine or RNA vaccine within one month before screening;
- Suffering from malignant tumors within 2 years prior to signing the ICF. Except for the following situations: non melanoma skin cancer that has undergone radical treatment, local prostate cancer, cervical carcinoma in...
- If a major surgery has been performed within 4 weeks prior to signing the informed consent form, or if a major surgery is planned during the study period, the researcher believes that it would pose unacceptable risks to...
- Not using immunosuppressants in the week before Qinglin treatment;
- Female participants with fertility potential who undergo pregnancy studies within 24 hours prior to the clearance of gonorrhea and have negative results;
- Blood oxygen saturation ≥ 92% (under non auxiliary oxygen supply conditions);
- Inactive or uncontrollable systemic infection; The use of anti infective drugs within 7 days before clearing gonorrhea must be reviewed by a medical inspector;
- No signs of CNS disease or abnormal neurological examination results with clinical significance;
- Serious abnormalities in heart, lung, liver, kidney function, and endocrine disorders, including but not limited to: newly developed arrhythmias or heart failure that cannot be controlled by medication; Hypotension...
- Researchers assess that participants are unable to comply with the requirements of the study protocol or are not suitable to continue the study in other situations. If a participant shows obvious abnormalities such as...
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Wuhan, Hubei, 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.