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Tests treatment safety and results for Systemic Lupus Erythematosus (SLE)
Official title A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Dynamics of Universal CD19 / 20 Car-t Cell Injection in Moderate to Severe Refractory Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT07339332
What this study is testing
- What it's testing
- This study is a single arm, open, exploratory dose escalation clinical study to evaluate the safety, efficacy, and cellular metabolic dynamics of ct1195e 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 65
You may be able to join if
- Voluntary signing of Informed Consent Form (ICF): I fully understand and am informed of this study, and I have signed the Informed Consent Form...
- When signing the ICF, the age should be between 18 and 65 years old (inclusive), with no gender restrictions;
- No systemic active infection (such as infectious pneumonia, tuberculosis) within 2 weeks before screening;
- Females with fertility (defined as all females who are physiologically capable of becoming pregnant) must agree to use highly effective contraception...
- Females with fertility must have a negative serum beta-human chorionic gonadotropin (β-hCG) test result at screening and within 48 hours prior to the...
You likely can't join if
- , blood transfusions and growth factors must not be used to meet these requirements;
- Liver function: defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ≤2× upper limit of normal (ULN), and total...
- Coagulation function: defined as an international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5×ULN;
- Lung function: When exposed to indoor air, the blood oxygen saturation (SpO2) is ≥92% (measured by a pulse oximeter);
- Cardiac function: defined as having a left ventricular ejection fraction (LVEF) of ≥50% as assessed by echocardiography (ECHO) within the 8 weeks...
- Those who have suffered from severe lupus nephritis within the previous 2 months and require hemodialysis, or have received prednisone ≥100 mg/d or...
See the full eligibility criteria
Who can join
- Voluntary signing of Informed Consent Form (ICF): I fully understand and am informed of this study, and I have signed the Informed Consent Form, expressing my willingness to follow and complete all research procedures;
- When signing the ICF, the age should be between 18 and 65 years old (inclusive), with no gender restrictions;
- No systemic active infection (such as infectious pneumonia, tuberculosis) within 2 weeks before screening;
- Females with fertility (defined as all females who are physiologically capable of becoming pregnant) must agree to use highly effective contraception from at least 28 days before the start of self-cleaning to 1 year...
- Females with fertility must have a negative serum beta-human chorionic gonadotropin (β-hCG) test result at screening and within 48 hours prior to the initiation of chemotherapy.
- Meet the EULAR/ACR 2019 classification criteria for SLE, with a disease history of ≥6 months;
- Prior to screening, patients must have received treatment with glucocorticoids combined with immunosuppressants (including cyclophosphamide, mycophenolate mofetil, tacrolimus, methotrexate, cyclosporine, leflunomide)...
- During screening, positive for antinuclear antibody, and/or positive for anti-ds-DNA antibody, and/or positive for anti-Smith antibody;
- During the screening period, patients with a SLEDAI-2K score of ≥7, or those with concurrent significant organ dysfunction, such as severe immune-mediated thrombocytopenia, lupus nephritis (histologically diagnosed as...
- During screening, involvement of active organs (including kidneys, heart and lungs, musculoskeletal system, blood system, blood vessels, etc.; involvement of skin and mucous membranes alone is not included) is present;
- Adequate organ function:
- Renal function: defined as creatinine clearance rate (Cockcroft-Gault) calculated without hydration assistance ≥ 50 mL/min;
- Bone marrow function: defined as absolute neutrophil count (ANC) ≥1.0×10\^9/L and hemoglobin (Hb) ≥60 g/L. During the 7 days prior to screening for inclusion and
What rules you out
- , blood transfusions and growth factors must not be used to meet these requirements;
- Liver function: defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ≤2× upper limit of normal (ULN), and total bilirubin levels ≤2× upper limit of normal (ULN)
- Coagulation function: defined as an international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5×ULN;
- Lung function: When exposed to indoor air, the blood oxygen saturation (SpO2) is ≥92% (measured by a pulse oximeter);
- Cardiac function: defined as having a left ventricular ejection fraction (LVEF) of ≥50% as assessed by echocardiography (ECHO) within the 8 weeks prior to screening. Exclusion Criteria:
- Those who have suffered from severe lupus nephritis within the previous 2 months and require hemodialysis, or have received prednisone ≥100 mg/d or equivalent hormone treatment for ≥14 days;
- Those who have undergone plasma exchange, plasma separation, hemodialysis within the previous 30 days, or those who have suffered from lupus crisis within the previous 30 days;
- Screen for individuals with a history of ≥ Grade 2 bleeding within the previous 30 days or those requiring long-term anticoagulant therapy;
- History of any of the following cardiovascular diseases within 30 days prior to screening: heart failure of NYHA class III or IV, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias...
- Before screening, there were manifestations of the central nervous system caused by lupus, including but not limited to lupus headache, seizures, cognitive impairment, impaired intellectual function, and visual...
- Individuals with central nervous system diseases prior to screening include, but are not limited to: cerebrovascular accident, encephalitis, epilepsy, convulsion/seizure, stroke, severe brain injury, dementia...
- Screen for the absence of systemic active infections within the previous 2 weeks, including but not limited to active tuberculosis;
- Previous exposure to CAR-T cell therapy or other gene-modified T cell therapies, or a history of major organ transplantation (such as heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation;
- Allergic or intolerant to diuretics, tocilizumab, or experiencing life-threatening allergic reactions, hypersensitivity reactions, or intolerance to CT1195E formulation or its excipients (including dimethyl sulfoxide...
- Screen for individuals who have used targeted B-cell drugs such as rituximab within the previous 3 months;
- Exclusion criteria: people who have used other biologics such as TACI-Ig and Benlysta within the previous 12 weeks;
- Within 2 weeks prior to the infusion of CT1195E, the use of prednisone (or equivalent drugs) at a dosage of ≥10 mg/day is allowed. Physiological substitutes, topical, and inhaled steroids are also permitted;
- Received T-cell-affecting immunosuppressants (mycophenolate mofetil, methotrexate, cyclosporine, azathioprine, leflunomide, tacrolimus) within 2 weeks before infusion of CT1195E;
- Have received JAK inhibitors (such as tofacitinib, baricitinib, ruxolitinib, etc.) within 2 weeks before the infusion of CT1195E;
- Have received attenuated live vaccine, inactivated vaccine, or RNA vaccine within one month before screening;
- Suffered from malignant tumor within 2 years before signing the ICF. The following conditions are excluded: non-melanoma skin cancer that has undergone radical treatment, localized prostate cancer, biopsy-confirmed...
- The participant has undergone major surgery within 4 weeks prior to signing the informed consent form, or plans to undergo major surgery during the study period, and the investigator believes that this would pose an...
- During screening, there is evidence of HIV, syphilis infection, active hepatitis B virus infection (HBsAg positive and HBV-DNA above the detection limit), or active hepatitis C virus infection (both HCV antibody and...
- Those who participated in other clinical studies within the previous three months or are still within the five half-lives after the last dose;
- Concurrent major chronic diseases that are not under control and that the investigator believes may increase the risk to study participants;
- people with a history or evidence of suicidal thoughts within the previous 6 months, or any suicidal behavior within the previous 12 months, are considered by the researchers to have a significant risk of suicide;
- Pregnant or lactating women;
- The researcher judges that the study participant has poor compliance, is unable or unwilling to adhere to the requirements of the study protocol, or has other reasons that make them unsuitable for participating in this...
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 65 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.