Actively Recruiting
Safety and Efficacy of SWK002 in Patients With D2T-Rheumatoid Arthritis
Led by The First Affiliated Hospital of University of Science and Technology of China · Updated on 2025-02-28
18
Participants Needed
1
Research Sites
120 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open label, single-site, dose-escalation study in up to 18 participants with refractory rheumatoid arthritis. This study aims to evaluate the safety and efficacy of the treatment with Anti-CD19 CART.
CONDITIONS
Official Title
Safety and Efficacy of SWK002 in Patients With D2T-Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- No gender restriction; age 18 years or older at consent signing
- Signed informed consent approved by Ethics Committee
- Adult refractory rheumatoid arthritis patients meeting 2010 ACR/EULAR criteria with treatment failures as defined
- Stable treatment with 1 or 2 conventional synthetic DMARDs prior to enrollment with specified dosing requirements
- No active or latent tuberculosis
- Adequate organ function including kidney, liver, and lung function as specified
- Hemodynamically stable with left ventricular ejection fraction of 45% or higher
- Agreement to use effective contraception for females of childbearing potential and all male subjects until specified time after treatment
You will not qualify if you...
- Malignant tumors
- History or current CNS disorders including seizures, cerebrovascular events, dementia, cerebellar disease, or autoimmune CNS involvement
- Prior allogeneic hematopoietic stem cell transplantation
- Chemotherapy other than pretreatment within 2 weeks before infusion
- Investigational drug therapy within 30 days before consent
- Active hepatitis B or C infection
- HIV or syphilis antibody positive
- Uncontrolled acute severe infections within 72 hours before infusion
- Blood loss or transfusion exceeding 400 mL within 2 months before screening
- History of drug or food allergies related to trial drugs or components
- Use of systemic cytotoxic or immunosuppressive agents within 6 months or localized agents within 30 days before screening or during study
- Pregnancy or lactation
- Systemic inflammatory diseases other than rheumatoid arthritis (except secondary Sjogren's syndrome)
- Unstable angina or myocardial infarction within 6 months before consent
- Other investigator-determined conditions such as poor compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hunan Siweikang Therapeutic Co.Ltd
Changsha, Hunan, China, 410119
Actively Recruiting
Research Team
Z
Zhu Chen Professor of medicine, M.D.
CONTACT
Z
Zhu Chen Professor, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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