Actively Recruiting
Treatment Study of BCMA-CD19 cCAR T Cells for 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
Researchers are evaluating the safety and tolerability of BCMA-CD19 cCAR T cells in adults aged 18 to 60 with refractory immune thrombocytopenia (ITP) linked to autoimmune diseases such as systemic lupus erythematosus and primary Sjogren's syndrome. This phase I, open-label, single-arm study addresses the challenge of persistent thrombocytopenia that leads to long hospital stays, costly treatments, and risk of serious bleeding. Current treatments like glucocorticoids and immunosuppressants sometimes fail, and newer biological agents do not fully eliminate the cells producing harmful antibodies. The study involves administering BCMA-CD19 cCAR T cells, which target and eliminate the antibody-producing B cells and plasma cells that contribute to disease. Patients receive these cells through intravenous injection after undergoing lymphodepleting chemotherapy. The treatment uses either fresh or thawed CAR T cells. The goal is to assess how well patients tolerate this therapy and to monitor safety. Participants will be closely monitored for up to 24 months after the CAR T cell infusion to track the number and incidence of any adverse events. Researchers will assess bleeding symptoms, platelet counts, and overall health throughout the study. Patients must give informed consent and will be evaluated for safety regularly to ensure their well-being during the trial.
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
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Trial Site Locations
Total: 1 location
1
West China Hospital
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
Q
Qibing Xie, MD
M
Min Yang, MD
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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