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New treatment option for Lupus Erythematosus, Systemic
Official title Exploratory Clinical Study of CNCT19 Anti CD19 Cell Therapy in the Treatment of Refractory Autoimmune Diseases
ClinicalTrials.gov ID: NCT06316791
What this study is testing
What is single dose of CNCT19?
single dose of CNCT19 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lupus erythematosus, systemic.
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
- Exploratory clinical study of CNCT19 anti CD19 cell therapy in the treatment of refractory autoimmune diseases,To evaluate the safety and tolerability of CNCT19 in patients with refractory systemic lupus erythematosus (lupus nephritis, immune thrombocytopenia), refractory ANCA-associated vasculitis, and refractory dermatomyositis on the basis of standard of care.
- 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
- The enrolled people or their legal representatives signed informed consent form;
- age range: 18-70 years (including 18 and 70 years), male or female;
- people with refractory systemic lupus erythematosus (lupus nephritis, immune thrombocytopenia) : Diagnosed with systemic lupus erythematosus...
- people with Refractory Systemic Lupus Erythematosus (Lupus Nephritis): Active and biopsy-confirmed proliferative lupus nephritis grade III or IV or...
- people with refractory systemic lupus erythematosus (thrombocytopenia): At least two consecutive blood routine examinations showed that platelet was...
You likely can't join if
- Patients with severe active central nervous system (CNS) lupus, including seizures, psychosis, cerebrovascular accident or CNS vasculitis requiring...
- Dialysis patients;
- Pregnancy or lactation;
- Concomitant uncontrollable infection (e.g., sepsis, bacteremia, fungemia, uncontrolled pulmonary infection, etc.);
- Hepatitis B surface antigen (HBsAg) positive and hepatitis C (HCV) antibody positive, human immunodeficiency virus (HIV) antibody positive, syphilis...
- Major surgery that was assessed as unsuitable by the investigator within 4 weeks before screening;
See the full eligibility criteria
Who can join
- The enrolled people or their legal representatives signed informed consent form;
- age range: 18-70 years (including 18 and 70 years), male or female;
- people with refractory systemic lupus erythematosus (lupus nephritis, immune thrombocytopenia) : Diagnosed with systemic lupus erythematosus according to American College of Rheumatology (ACR) criteria, accompanied by...
- people with Refractory Systemic Lupus Erythematosus (Lupus Nephritis): Active and biopsy-confirmed proliferative lupus nephritis grade III or IV or simple grade V alone according to 2003 ISN/RPS criteria. Active renal...
- people with refractory systemic lupus erythematosus (thrombocytopenia): At least two consecutive blood routine examinations showed that platelet was lower than 50x109/L; Blood cell morphology of peripheral blood smear...
- people with refractory ANCA-associated vasculitis: diagnosis of ANCA glomerulonephritis (GN) or vasculitis based on the 2013 American Chapel Hill Consensus Conference definition of AAV ;
- Relapsed or refractory AAV requiring treatment with cyclophosphamide or rituximab
- Newly diagnosed or recurrent AAV--, defined as accumulation of at least one major organ (e.g., kidney, lung, heart) requiring induction therapy with cyclophosphamide or rituximab;
- Anti-PR3 or anti-MPO positive (current or history);
- people with Refractory Dermatomyositis: Refractory MDA5-positive dermatomyositis is defined as active disease and meets the following conditions: adequate corticosteroid therapy (greater than two to four weeks of...
- Use of ≥ 1 conventional immunosuppressive agent (eg, methotrexate, azathioprine, tacrolimus, cyclosporine, mycophenolate mofetil, IVIG, anti-TNF, or rituximab) at a reasonable dose and duration (greater than two to four...
- Treatment with IVIG or cyclophosphamide for two to four weeks.
- Women of childbearing potential must have a negative blood pregnancy test 7 days prior to trial conditioning therapy; any male and female patients of childbearing potential must agree to use an effective method of...
- Hysterectomy or oophorectomy, or
- Medically confirmed ovarian failure, or medically confirmed postmenopausal (cessation of menses for at least 12 consecutive months in the absence of pathological or physiological causes).
- Adequate organ function according to the following criteria:
- Aspartate aminotransferase (AST) ≤ 3 times of upper limit of normal (ULN);
- Alanine aminotransferase (ALT) ≤ 3 times ULN;
- Total serum bilirubin ≤ 2 times ULN unless the patient has documented Gilbert's syndrome; patients with Gilbert's syndrome who have bilirubin ≤ 3.0 times ULN and direct bilirubin ≤ 1.5 times ULN may be included;
- Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL/min (Cockcroft and Gault formula), Patients with lupus nephritis may relax the conditions appropriately according to the judgment of the investigator;
- Must have minimal pulmonary reserve and oxygen saturation \> 91% in a nonoxygenated state;
- Lymphocyte count \> 0.4 × 109/L.
What rules you out
- Patients with severe active central nervous system (CNS) lupus, including seizures, psychosis, cerebrovascular accident or CNS vasculitis requiring therapeutic intervention within 60 days after baseline;
- Dialysis patients;
- Pregnancy or lactation;
- Concomitant uncontrollable infection (e.g., sepsis, bacteremia, fungemia, uncontrolled pulmonary infection, etc.);
- Hepatitis B surface antigen (HBsAg) positive and hepatitis C (HCV) antibody positive, human immunodeficiency virus (HIV) antibody positive, syphilis (TP) positive;
- Major surgery that was assessed as unsuitable by the investigator within 4 weeks before screening;
- Patient's heart meets any of the following:
- Left ventricular ejection fraction (LVEF) ≤ 45%;
- New York Heart Association (NYHA) Class III or IV congestive heart failure or active cardiac disease;
- Serious arrhythmia requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia);
- QTc interval ≥ 450 ms for males and ≥ 470 ms for females (QTcB = QT/RR1/2);
- Myocardial infarction, bypass surgery or stent surgery within 6 months prior to the study;
- Other cardiac diseases that are not suitable for the study as judged by the investigator;
- Received live vaccine within 6 weeks prior to screening.
- Participation in other treatment clinical studies within 3 months prior to cell infusion, treatment with an active experimental drug, or intentional participation in another clinical trial or treatment outside of that...
- Patients with a history of epilepsy or other active central nervous system diseases;
- Known hypersensitivity to the ingredients of the preparation used in the test;
- Prior treatment with CAR-T cells.
- Other conditions that the investigator considers inappropriate for participation in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, 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.