Actively Recruiting
Safety and Efficacy Study of CD19-CAR-DNT Cells in Autoimmune Diseases
Led by RenJi Hospital · Updated on 2024-03-18
48
Participants Needed
1
Research Sites
135 weeks
Total Duration
On this page
Sponsors
R
RenJi Hospital
Lead Sponsor
G
Guangdong Ruishun Biotech Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
To evaluate the safety and efficacy of CD19-CAR-DNT cells in subjects with relapsed/refractory autoimmune diseases
CONDITIONS
Official Title
Safety and Efficacy Study of CD19-CAR-DNT Cells in Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent and plan to complete study follow-up and treatment
- Aged 18 to 75 years, any gender
- Adequate organ function within 7 days before chemotherapy, including coagulation, liver, kidney, blood counts, and heart function
- Female patients of childbearing potential must have a negative pregnancy test and agree to use effective contraception for at least six months after consent
- Female patients without childbearing potential must meet specific criteria such as hysterectomy, ovarian failure, or post-menopause
- Diagnosed with relapsed or refractory autoimmune diseases as defined by 2022 EULAR/ACR criteria
You will not qualify if you...
- History of severe drug allergies or allergic constitution
- Active infections including tuberculosis, CNS infection, hepatitis, enteritis
- Serious diseases like malignant tumors, end-stage kidney failure, alveolar hemorrhage needing ventilation, acute mononeuritis multiplex, or CNS involvement
- Kidney disease with creatinine clearance below 60 mL/min or serum creatinine over 1.5 times normal before chemotherapy
- Cardiovascular diseases including unstable angina, recent stroke or heart attack, severe heart failure, refractory hypertension, or severe arrhythmia
- Other uncontrolled acute or chronic diseases that may affect study results
- Positive for hepatitis B, hepatitis C, HIV, cytomegalovirus, or syphilis infections
- Active or uncontrollable infections requiring systemic treatment
- Vaccination with live or attenuated live vaccines within 1 month before screening
- Previous or planned organ transplant
- Prior CAR-T or gene-modified cell therapy
- Recent rituximab, belimumab, telitacicept, or JAK inhibitor treatment within specified time frames
- Life expectancy less than 3 months
- Participation in other clinical trials within 3 months prior to screening
- Any medical condition or investigator judgment that poses unacceptable risk to the participant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Rheumatology, Ren Ji Hospital South Campus, School of Medicine, Shanghai JiaoTong University
Shanghai, China
Actively Recruiting
Research Team
Q
Qiong Fu, MD, PhD
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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