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
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 the subject or legal representative
- Age between 18 and 70 years, male or female
- Diagnosed with refractory systemic lupus erythematosus (lupus nephritis or immune thrombocytopenia) according to established criteria and receiving standard treatment
- For lupus nephritis: active, biopsy-confirmed proliferative lupus nephritis grade III or IV or grade V with proteinuria >3.5 grams/day
- For lupus thrombocytopenia: platelet count lower than 50x10^9/L in at least two blood tests, normal blood cell morphology, and platelet count >10x10^9/L
- Diagnosed with refractory ANCA-associated vasculitis requiring or having received cyclophosphamide or rituximab treatment
- Diagnosed with refractory MDA5-positive dermatomyositis with active disease despite corticosteroids and at least one immunosuppressive agent or intolerance to therapy
- Negative blood pregnancy test within 7 days before treatment for women of childbearing potential
- Agree to use effective contraception during the study and for 1 year after treatment
- Adequate organ function with specific laboratory and clinical criteria as defined
You will not qualify if you...
- Severe active central nervous system lupus requiring treatment within 60 days before screening
- Patients on dialysis
- Pregnant or lactating women
- Uncontrolled infections such as sepsis or fungemia
- Positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or syphilis
- Major surgery within 4 weeks before screening
- Certain heart conditions including low ejection fraction, severe heart failure, serious arrhythmias, recent myocardial infarction or cardiac surgery, or other cardiac diseases unsuitable for study
- Received live vaccine within 6 weeks before screening
- Participation in other interventional clinical trials within 3 months before cell infusion
- 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 unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
Research Team
R
Ruijiao Huang
CONTACT
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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