Actively Recruiting
CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Relapse/Refractory Autoimmune Diseases
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-01-20
12
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
S
Shanghai Xiniao Biotech Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Relapse/Refractory Autoimmune Diseases
CONDITIONS
Official Title
CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Relapse/Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Adequate bone marrow function with neutrophil count ≥ 1 x 10^9/L and hemoglobin ≥ 60g/L
- Liver function with ALT and AST ≤ 3 times upper limit of normal (excluding elevations due to inflammatory myopathy), total bilirubin ≤ 2 times upper limit of normal (or ≤ 3 times for Gilbert syndrome)
- Renal function with creatinine clearance ≥ 30 mL/min (excluding acute decreases due to target disease)
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before enrollment and not be breastfeeding
- Use of medically approved contraception or abstinence during the study and for at least 6 months after treatment for females of childbearing potential and males with partners of childbearing potential
- Willingness to participate, sign informed consent, and comply with study follow-up
- Diagnosis of refractory or relapsed systemic lupus erythematosus meeting classification criteria with disease activity or organ involvement and refractory to conventional therapy
- Diagnosis of refractory, relapsed, or progressive systemic sclerosis meeting classification criteria with specific antibody positivity and clinical features, including ineffective conventional treatment or disease progression
- Diagnosis of refractory, relapsed, or progressive inflammatory myopathy meeting classification criteria with muscle involvement and specific activity scores, refractory or progressive disease
- Diagnosis of refractory or relapsed ANCA-associated vasculitis meeting classification criteria with active disease and positive antibodies, refractory to conventional therapy
- Diagnosis of refractory or relapsed connective tissue disease-associated thrombocytopenia with low platelet counts and prior inadequate response to corticosteroids and immunosuppressants
You will not qualify if you...
- History of severe drug allergies or allergic tendencies
- Presence or suspicion of uncontrolled or requiring treatment infections (fungal, bacterial, viral, or others)
- Central nervous system diseases caused by autoimmune or non-autoimmune causes including epilepsy, psychosis, organic brain syndrome, stroke, encephalitis, or CNS vasculitis
- Insufficient cardiac function
- Congenital immunoglobulin deficiencies
- History of cancer within the past five years
- End-stage renal failure (except lupus nephritis)
- Positive for hepatitis B surface antigen or core antibody with detectable HBV DNA; positive for hepatitis C antibody with detectable RNA; HIV positive; or positive syphilis test
- Psychiatric disorders or severe cognitive impairments
- Participation in other clinical trials within 3 months prior to enrollment
- Use of immunosuppressive agents or biologics within five half-lives before enrollment
- Pregnant women or women planning to conceive
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, China, China
Actively Recruiting
Research Team
Y
Ying Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
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