Actively Recruiting
BCMA-CD19 CCAR T Cell Treatment of Refractory Immune Thrombocytopenia Associated with Autoimmune Diseases
Led by iCell Gene Therapeutics · Updated on 2025-01-22
20
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
Sponsors
I
iCell Gene Therapeutics
Lead Sponsor
I
iCell ImmunityX（Hangzhou）Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19 cCAR T cells in patients with refractory ITP associated with autoimmune disease.
CONDITIONS
Official Title
BCMA-CD19 CCAR T Cell Treatment of Refractory Immune Thrombocytopenia Associated with Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years old
- Diagnosed with immune thrombocytopenia linked to autoimmune diseases including systemic lupus erythematosus, primary Sjogren's syndrome, or undifferentiated connective tissue disease
- Patients without clinical symptoms of connective tissue disease but with positive anti-nuclear antibodies (≥1:100) and/or positive anti SSA/Ro-52 antibodies
- Serum creatinine less than 221.0 µmol/L (2.5 mg/dl)
- Platelet count less than 30 × 10⁹/L or platelet count ≥ 20 × 10⁹/L with bleeding symptoms (bleeding symptom score ≥ 2 points)
- No active infection
- Voluntary participation with informed consent signed by the patient or legal representative
You will not qualify if you...
- Serious accompanying diseases considered clinically significant and poorly controlled, such as neurological, cardiovascular, renal, liver, endocrine, or gastrointestinal diseases
- Active central nervous system lupus including epilepsy, psychosis, encephalopathy, stroke, encephalitis, or CNS vasculitis
- Visual disorders or cranial neuropathy requiring intervention
- Abnormal liver function with AST, ALT, or GGT levels greater than 1.5 times the upper limit of normal
- Urinary protein quantification greater than 1 g/24h
- History of malignant tumors
- Active hepatitis B or C infection or HIV positive
- History of drug allergies or other allergies
- Any other clinically significant disease or condition that may risk safety or interfere with study completion and evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
Q
Qibing Xie, MD
CONTACT
M
Min Yang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here