Actively Recruiting
A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Dynamics of Universal CD19 / 20 Car-t Cell Injection in Moderate to Severe Refractory Systemic Lupus Erythematosus
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2026-01-14
12
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
C
CARsgen Therapeutics Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a single arm, open, exploratory dose escalation clinical study to evaluate the safety, efficacy, and cellular metabolic dynamics of ct1195e cells in patients with SLE.
CONDITIONS
Official Title
A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Dynamics of Universal CD19 / 20 Car-t Cell Injection in Moderate to Severe Refractory Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed informed consent form
- Age between 18 and 65 years inclusive, any gender
- No systemic active infection within 2 weeks before screening
- Females capable of pregnancy agree to use effective contraception from 28 days before treatment to 1 year after infusion
- Male partners of fertile females agree to use effective barrier contraception during the study
- Negative serum beta-hCG test for fertile females at screening and within 48 hours before treatment
- Meet EULAR/ACR 2019 classification criteria for SLE with disease history of at least 6 months
- Prior treatment with glucocorticoids combined with immunosuppressants and/or biologics for at least 3 months with stable dosage for 2 weeks, with active disease
- During screening, positive for antinuclear antibody and/or anti-ds-DNA antibody and/or anti-Smith antibody
- SLEDAI-2K score of 7 or higher at screening or significant organ dysfunction
- Active involvement of organs such as kidneys, heart, lungs, musculoskeletal, blood, or vessels (skin/mucous membrane alone excluded)
- Adequate organ function including renal, bone marrow, liver, coagulation, lung, and cardiac function as specified
You will not qualify if you...
- Severe lupus nephritis within 2 months requiring hemodialysis or prednisone ≥100 mg/day for ≥14 days
- Plasma exchange, plasma separation, or hemodialysis within 30 days or lupus crisis within 30 days
- History of grade 2 or higher bleeding or long-term anticoagulant therapy within 30 days
- Cardiovascular diseases like heart failure NYHA III/IV, recent myocardial infarction, unstable angina, or serious arrhythmias within 30 days
- Central nervous system lupus manifestations or diseases including seizures, stroke, dementia, or psychosis before screening
- Systemic active infections within 2 weeks before screening including active tuberculosis
- Previous CAR-T or gene-modified T cell therapy or major organ/bone marrow transplantation
- Allergy or intolerance to diuretics, tocilizumab, CT1195E or its components
- Use of targeted B-cell drugs like rituximab within 3 months
- Use of other biologics such as TACI-Ig or Benlysta within 12 weeks
- Use of prednisone ≥10 mg/day, T-cell affecting immunosuppressants, or JAK inhibitors within 2 weeks before infusion
- Vaccination with live, inactivated, or RNA vaccines within 1 month before screening
- Malignant tumors within 2 years except certain treated cancers
- Major surgery within 4 weeks before consent or planned during study
- Evidence of HIV, syphilis, active hepatitis B or C infections
- Participation in other clinical studies within 3 months or within 5 half-lives of last dose
- Uncontrolled major chronic diseases increasing participant risk
- History or evidence of suicidal thoughts or behaviors within specified periods
- Pregnant or breastfeeding women
- Poor compliance or unwillingness to follow study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wuhan Union Hospita
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
Q
Qiubai Li
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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