Actively Recruiting
Exploratory Clinical Study of CNCT19 Anti CD19 Cell Therapy in the Treatment of Refractory Autoimmune Diseases
Led by Juventas Cell Therapy Ltd. · Updated on 2025-02-10
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CNCT19, an anti CD19 cell therapy, in patients with certain difficult-to-treat autoimmune diseases, including refractory systemic lupus erythematosus (such as lupus nephritis and immune thrombocytopenia), refractory ANCA-associated vasculitis, and refractory dermatomyositis. This early phase 1 study aims to assess the safety and tolerability of CNCT19 alongside standard care treatments for these conditions. The study is sponsored by Juventas Cell Therapy Ltd. and focuses on patients who have not responded well to previous therapies. Participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide before getting a single intravenous infusion of CNCT19, which consists of autologous second-generation CD19-directed CAR-T cells. This investigational treatment is given once, and patients will be closely monitored for up to one year after the infusion. The treatment is designed to evaluate how well patients tolerate CNCT19 and any related effects. During the study, participants will undergo various assessments including monitoring for treatment-emergent adverse events, measuring overall survival, and evaluating disease activity using tools like SELENA-SLEDAI. Researchers will also track use of glucocorticoids and immunosuppressants and analyze disease-related biomarkers throughout the one-year follow-up. Participants will have regular visits for safety checks and laboratory tests to help understand the therapy's effects over time.
CONDITIONS
Brief Title
Exploratory Clinical Study of CNCT19 Anti CD19 Cell Therapy in the Treatment of Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form by participant or legal representative
- Age between 18 and 70 years, male or female
- Diagnosed with refractory systemic lupus erythematosus with lupus nephritis or immune thrombocytopenia and receiving standard treatment
- For lupus nephritis: active and biopsy-confirmed proliferative lupus nephritis grade III, IV, or simple grade V, with active renal disease defined by specific proteinuria criteria
- For immune thrombocytopenia: platelet count lower than 50x10^9/L on at least two tests, normal blood cell morphology, no enlarged spleen, and bone marrow features indicating megakaryocytic increase or normal with maturation disorder, platelet count above 10x10^9/L
- Diagnosed with refractory ANCA-associated vasculitis including relapsed or refractory disease requiring cyclophosphamide or rituximab, or newly diagnosed/recurrent disease with major organ involvement, anti-PR3 or anti-MPO positive
- Diagnosed with refractory MDA5-positive dermatomyositis with active disease and prior corticosteroid or immunosuppressive treatment or intolerance
- Women of childbearing potential must have a negative pregnancy test before conditioning and agree to use effective contraception during and for one year after treatment; definitions for childbearing potential are specified
- Adequate organ function including liver enzymes, bilirubin, kidney function, pulmonary reserve, oxygen saturation, and lymphocyte count within defined limits
You will not qualify if you...
- Severe active central nervous system lupus requiring intervention within 60 days prior to baseline
- Patients on dialysis
- Pregnancy or breastfeeding
- Uncontrolled infections such as sepsis or pulmonary infections
- Positive for hepatitis B, hepatitis C, HIV, or syphilis
- Major surgery within 4 weeks before screening deemed unsuitable
- Heart conditions including low ejection fraction, advanced heart failure, serious arrhythmias, prolonged QTc interval, recent heart surgery, or other unsuitable cardiac diseases
- Receipt of live vaccine within 6 weeks before screening
- Participation in other interventional clinical studies within 3 months prior to cell infusion or concurrent participation outside the protocol
- History of epilepsy or other active central nervous system diseases
- Known allergy to study treatment ingredients
- Prior treatment with CAR-T cells
- Other conditions deemed inappropriate by the investigator for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single dose with follow-up for up to 1 year
Participants receive a conditioning chemotherapy regimen followed by a single intravenous infusion of CNCT19 anti CD19 cell therapy.
1 conditioning visit, 1 infusion visit, and multiple follow-up visits over 1 year
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
Research Team
R
Ruijiao Huang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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