Actively Recruiting
Allogeneic UCB-derived CAR-T for SLE
Led by Chengdu Ucello Biotechnology Co., Ltd. · Updated on 2025-12-10
48
Participants Needed
2
Research Sites
666 weeks
Total Duration
On this page
Sponsors
C
Chengdu Ucello Biotechnology Co., Ltd.
Lead Sponsor
T
The General Hospital of Western Theater Command
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this clinical trial is to learn if allogeneic, umbilical cord blood-derived chimeric antigen receptor T-cell (UCAR-T) targeting CD19 and BCMA works to treat refractory SLE in adults. It will also learn about the safety and efficacy of the UCAR-T cell product.
CONDITIONS
Official Title
Allogeneic UCB-derived CAR-T for SLE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years (inclusive), regardless of gender.
- Definitive diagnosis of systemic lupus erythematosus (SLE) meeting the 2019 EULAR/ACR classification criteria.
- Treatment refractory: failed 2 or more conventional SLE treatments for at least 3 months.
- Disease activity with SELENA-SLEDAI score of 6 or higher plus at least one BILAG-2004 Class A or two Class B organ scores; or SELENA-SLEDAI score of 8 or higher.
- Adequate major organ function including bone marrow, liver, kidney, coagulation, and stable cardiac function.
- Female and male subjects of childbearing potential must use approved contraception or abstain during treatment and for 6 months after.
- Female subjects of childbearing potential must have a negative serum HCG test within 7 days before enrollment and must not be breastfeeding.
- Voluntary participation with signed informed consent and good compliance with study procedures and follow-up.
You will not qualify if you...
- History of severe drug allergies or atopic diathesis.
- Presence or suspicion of uncontrolled or treatment-requiring fungal, bacterial, viral, or other infections.
- Cardiac function insufficient to tolerate study treatment.
- Congenital immunoglobulin deficiency.
- History of malignant tumors within the past 5 years.
- End-stage renal failure.
- Positive hepatitis B surface antigen and core antibody with detectable HBV DNA; positive hepatitis C antibody with detectable HCV RNA; positive HIV antibody; positive syphilis test.
- History of mental illness or severe cognitive impairment.
- Use of disease-modifying immunosuppressive agents within 5 half-lives or biological agents within 4 weeks before enrollment.
- Pregnant females or females planning to become pregnant.
- Other conditions deemed by the investigator to preclude study participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Yancheng Third People's Hospital
Yancheng, Jiangsu, China
Actively Recruiting
2
The General Hospital of Western Theater Command
Chengdu, Sichuan, China
Not Yet Recruiting
Research Team
T
Tao Wang, M.D.
CONTACT
X
Xia zhao He, M.D. & Ph.D.
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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