Actively Recruiting
Clinical Study on the Safety and Efficacy of CD19-BCMA CAR-T Cell Therapy for Connective Tissue Diseases
Led by Guangzhou Bio-gene Technology Co., Ltd · Updated on 2025-09-03
20
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-arm, single-center Investigator-Initiated Trial (IIT) designed to evaluate the safety, pharmacokinetic profile, and preliminary efficacy of CD19-BCMA CAR-T cells in subjects diagnosed with connective tissue diseases.
CONDITIONS
Official Title
Clinical Study on the Safety and Efficacy of CD19-BCMA CAR-T Cell Therapy for Connective Tissue Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients or guardians voluntarily sign informed consent and can complete all study procedures and follow-ups
- Diagnosis of one of the following connective tissue diseases based on latest criteria: systemic lupus erythematosus, rheumatoid arthritis, systemic scleroderma, Sjogren's syndrome, polymyositis/dermatomyositis, or mixed connective tissue disease
- Disease is currently active as determined by researchers
- At least one autoantibody positive in serum or plasma at screening
- Insufficient response, intolerance, or recurrence after at least one standard treatment
- Negative pregnancy test for females and agreement to use effective contraception during the trial
- Major organs and tissues are functioning well
You will not qualify if you...
- Intracranial hypertension or confusion
- Symptomatic heart failure or severe arrhythmia
- Respiratory failure
- Presence of other malignant tumors
- Diffuse vascular coagulation
- Serum creatinine and/or urea nitrogen equal to or greater than 1.5 times normal value
- Sepsis or other difficult-to-control infections
- Uncontrollable diabetes
- Severe mental disorder
- Obvious intracranial lesions found by cranial MRI
- WHO physical status classification level 3 or higher
- Organ transplant recipients
- Pregnant or breastfeeding women
- Positive for HIV, HBV, HCV, EBV, or CMV
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Dongguan Taixin Hospital
Dongguan, Guangdong, China, 523125
Actively Recruiting
Research Team
Y
Yuelin He, Ph.D. degree
CONTACT
L
Lan He, Ph.D. degree
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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