SSc-Systemic Sclerosis study: CAR-T Therapy
Official title Safety, Efficacy and Cellular Metabolic Dynamics of CT1195E in Patients With Refractory / Progressive SSC
ClinicalTrials.gov ID: NCT07355972
What this study is testing
- What it's testing
- This study is a single arm, exploratory dose escalation clinical study to look at the safety, how well it works, and cellular metabolic dynamics of ct1195e cells in patients with 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
- voluntarily sign the informed consent form (ICF): I fully understand and know this study and sign the informed consent form.
- when signing ICF, the age is between 18 and 60 years old (including 18 and 60 years old), regardless of gender;
- no systemic active infection (such as infectious pneumonia and tuberculosis) within 2 weeks before screening;
- women with fertility (defined as all women who are physically able to conceive) must agree to use efficient contraceptive methods from at least 28...
- women with fertility must be tested negative for serum β human chorionic gonadotropin (β -hcg) at the time of screening and within 48 hours before...
You likely can't join if
- FVC ≤ 30% predicted value or DLCO (corrected by hemoglobin) ≤ 30% predicted value;
- study participants with severe kidney disease or signs of renal crisis;
- there is active tuberculosis risk during screening: there are signs or symptoms of active tuberculosis judged by the investigator (such as fever...
- have previously received car-t cell or other gene modified T cell therapy, or have a history of major organ transplantation (such as heart, lung...
- have used drugs targeting B cells (such as rituximab) within 3 months before screening;
- allergic or intolerant to Qinglin drugs and tocilizumab, or life-threatening allergic reaction, hypersensitivity reaction or intolerance to ct1195e...
See the full eligibility criteria
Who can join
- voluntarily sign the informed consent form (ICF): I fully understand and know this study and sign the informed consent form. I am willing to follow and be able to complete all research procedures;
- when signing ICF, the age is between 18 and 60 years old (including 18 and 60 years old), regardless of gender;
- no systemic active infection (such as infectious pneumonia and tuberculosis) within 2 weeks before screening;
- women with fertility (defined as all women who are physically able to conceive) must agree to use efficient contraceptive methods from at least 28 days before the start of gonorrhea to 1 year after ct1195e infusion, and...
- women with fertility must be tested negative for serum β human chorionic gonadotropin (β -hcg) at the time of screening and within 48 hours before gonorrhea treatment.
- meet the 2013 eular/acr classification criteria for systemic sclerosis, and meet the diffuse manifestations, and the disease duration is ≤ 7 years (the onset time of the disease duration is defined as the time of the...
- complicated with interstitial pneumonia, that is, the interstitial changes of ground glass exudation suggested by chest HRCT;
- Definition of refractory: the conventional treatment for more than 6 months is still ineffective, or the disease relapses after remission.
- Aggravation of symptoms;
- FVC estimated value decreases by 5%, or DLCO estimated value decreases by 10%;
- Pulmonary imaging aggravated;
- Renal function: defined as creatinine clearance (Cockcroft Gault) ≥ 50 ml/min calculated without hydration assistance;
- Bone marrow function: defined as neutrophil (ANC) ≥ 1.0 × 109/l, hemoglobin (HB) ≥ 90 g/l. Blood transfusion and growth factors shall not be used to meet the above requirements within 7 days before the eligibility...
- Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 × upper limit of normal (ULN), total bilirubin ≤ 2 × upper limit of normal (ULN)
- Coagulation function: INR ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN;
- Cardiac function: good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥ 40%.
What rules you out
- FVC ≤ 30% predicted value or DLCO (corrected by hemoglobin) ≤ 30% predicted value;
- study participants with severe kidney disease or signs of renal crisis;
- there is active tuberculosis risk during screening: there are signs or symptoms of active tuberculosis judged by the investigator (such as fever, cough, night sweat and weight loss)
- have previously received car-t cell or other gene 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;
- have used drugs targeting B cells (such as rituximab) within 3 months before screening;
- allergic or intolerant to Qinglin drugs and tocilizumab, or life-threatening allergic reaction, hypersensitivity reaction or intolerance to ct1195e preparation or its excipients (including dimethyl sulfoxide (DMSO), or...
- prednisone (≥ 10 mg / day) (or equivalent drug) is used for hormones within 2 weeks before ct1195e infusion, and physiological replacement, local and inhalation hormones are allowed;
- received immunosuppressants affecting T cells (mycophenolate mofetil, methotrexate, cyclosporine, azathioprine, leflunomide, tacrolimus) within 2 weeks before infusion of ct1195e;
- received JAK inhibitors (tofacitinib, baricitinib tablets, lucotinib, etc.) within 2 weeks before ct1195e infusion;
- have been vaccinated with live attenuated vaccine, inactivated vaccine or RNA vaccine within 1 month before screening;
- suffering from malignant tumor within 2 years before signing ICF. Except for the following cases: non melanoma skin cancer after radical treatment, local prostate cancer, cervical carcinoma in situ confirmed by biopsy...
- major surgery has been performed within 4 weeks before signing the informed consent, or major surgery is planned to be required during the study, which the investigator believes will bring unacceptable risks to the...
- HIV, syphilis infection, active hepatitis B virus infection (HBsAg positive and HBV-DNA above the detection limit), or active hepatitis C virus infection (HCV antibody and HCV-RNA positive) were present at the time of...
- those with CNS diseases before screening include but are not limited to: cerebrovascular accident, encephalitis, epilepsy, convulsion / convulsion, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar...
- have a history of any of the following cardiovascular diseases within 1 month before screening: Grade III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any...
- participate in other clinical studies within 3 months before screening or still within five half lives after the last medication.
- there is currently any uncontrollable active infection, including but not limited to active tuberculosis;
- if there is a history of suicidal thoughts or evidence within 6 months before signing the ICF, or any suicidal behavior within 12 months before signing the ICF, the investigator believes that there is a significant risk...
- pregnant or lactating women;
- the investigator judged that the study participants had poor compliance, were unable or unwilling to comply with the requirements of the study protocol, or were not suitable to participate in the clinical study for...
The study team makes the final eligibility decision.
Where it is enrolling
- Wuhan, Hubei, 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, but 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?
This study is enrolling now at Wuhan, Hubei, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.