Actively Recruiting
Study of CD19 CAR-T Therapy for Refractory SLE
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2026-02-11
18
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an investigator-initiated trial aimed at assessing the safety and efficacy of PTOC1 cells Injection in the treatment of refractory systemic lupus erythematosus.
CONDITIONS
Official Title
Study of CD19 CAR-T Therapy for Refractory SLE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 5 years or older, any gender
- Diagnosed with SLE according to 2019 EULAR/ACR criteria
- Moderate to severe disease activity despite at least 3 months of high-dose glucocorticoids plus hydroxychloroquine and at least two immunosuppressants or biologics, or intolerant to standard treatments
- SLEDAI-2K score of 8 points or higher
- Cardiac function: left ventricular ejection fraction (LVEF) of 50% or higher with no major ECG abnormalities
- Renal function: estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73m2 or higher
- Liver function: AST and ALT no more than 3 times upper limit of normal; total bilirubin no more than 2 times upper limit of normal
- Pulmonary function: no severe lung lesions; blood oxygen saturation of 92% or higher without oxygen
- Eligible for leukapheresis or intravenous blood collection with no contraindications
- Negative pregnancy test if female of childbearing age and agreement to use contraception for one year after infusion
- Participant or guardian provides informed consent and agrees to participate
You will not qualify if you...
- Central nervous system diseases needing intervention within 60 days, including epilepsy, confusion, cerebrovascular events
- Congenital heart disease or severe arrhythmia before screening, including frequent tachycardias or severe myocarditis
- Unstable vital signs requiring vasopressors
- Active infections requiring systemic treatment or uncontrolled infections within 3 months prior to screening
- Received solid organ or hematopoietic stem cell transplantation within 3 months prior to screening, or acute graft-versus-host disease grade 2 or above within 2 weeks prior
- Positive for hepatitis B surface antigen or core antibody with high HBV DNA, hepatitis C antibody with high HCV RNA, HIV antibody, or treponema pallidum antibody
- History of macrophage activation syndrome within 1 month prior to screening unless cleared by investigator
- Prior CAR-T therapy unless deemed safe by investigator
- Active pulmonary tuberculosis at screening
- Vaccination within 4 weeks prior to screening
- Positive blood pregnancy test
- Diagnosis of malignant tumors prior to screening
- Participation in other clinical trials within 3 months prior to enrollment
- Other conditions deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Children's Hospital of Chongqing Medical University
Chongqing, China
Actively Recruiting
Research Team
X
Xiaodong Zhao
CONTACT
Y
Yunfei An
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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