Actively Recruiting
Exploratory Clinical Study of Anti-CD19/BCMA Universal CAR-T Cell Injection for the Treatment of Refractory Autoimmune Diseases
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-04-30
72
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
R
Rui Therapeutics Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA-UCAR-T cells in patients with autoimmune diseases. 36-72 patients are planned to be enrolled in the dose-escalation trial.
CONDITIONS
Official Title
Exploratory Clinical Study of Anti-CD19/BCMA Universal CAR-T Cell Injection for the Treatment of Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent and be willing and able to complete all trial procedures
- Age 18 to 70 years, any gender
- Peripheral blood CD19-positive B cells > 5 cells/µL at screening
- For those previously treated with B-cell therapy, B cell counts must have returned to normal or above pre-treatment levels
- For Sjögren's disease patients, specific blood counts within normal limits before lymphodepleting chemotherapy
- Adequate liver, kidney, lung, and heart function as defined by study criteria
- Negative pregnancy test for fertile females; use of effective contraception for fertile males and females during study and 1 year after
- Specific diagnostic and disease activity criteria for rheumatoid arthritis, dermatomyositis, systemic lupus erythematosus, and systemic sclerosis as detailed in the protocol
You will not qualify if you...
- History of malignant tumors (except certain cured skin and cervical cancers) or current malignant tumors
- Severe pulmonary diseases including high-grade pulmonary hypertension and need for oxygen therapy or ventilation
- Allergy or intolerance to study treatments or history of severe anaphylactic reactions
- Severe active infections including viral, bacterial, or fungal infections at screening
- Significant cardiac conditions including heart failure class III or IV, recent myocardial infarction, severe arrhythmias, or myocarditis
- Active infections requiring intravenous antibiotics
- Positive tests for hepatitis B or C, HIV, syphilis, or cytomegalovirus with high viral loads
- Recent herpes infections or signs of varicella-zoster virus infection
- Active or history of tuberculosis without confirmed negative testing
- History of epilepsy or active CNS disorders
- Known immunodeficiency diseases
- Significant medical conditions that may interfere with treatment
- Recent organ or stem cell transplantation or acute graft-versus-host disease
- Recent live vaccine administration
- Recent treatments with B-cell depleting therapies or other specified immunomodulatory therapies within defined time frames
- Participation in other clinical trials within 3 months unless no investigational drugs were received
- Specific exclusion criteria for rheumatoid arthritis, dermatomyositis, systemic lupus erythematosus, and systemic sclerosis as detailed in the protocol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University (Jiangsu Province Hospital)
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
W
Wenfeng Tan
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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