Actively Recruiting
Safety, Efficacy and Cellular Metabolic Dynamics of ct1192 in Patients With Moderate to Severe Refractory SLE
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-11-24
12
Participants Needed
1
Research Sites
89 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
A clinical study to explore the safety, efficacy and cell metabolic kinetics of universal CD19/20 car-t cell injection in moderate to severe refractory systemic lupus erythematosus. This study is a single arm, open, exploratory dose increasing clinical study, which aims to evaluate the safety, efficacy and cell metabolic dynamics of ct1192 cells in patients with SLE.
CONDITIONS
Official Title
Safety, Efficacy and Cellular Metabolic Dynamics of ct1192 in Patients With Moderate to Severe Refractory SLE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet the EULAR/ACR 2019 SLE classification criteria with at least 6 months of medical history
- Aged between 18 and 60 years at the time of informed consent, any gender
- No active systemic infections like pneumonia or tuberculosis within 2 weeks before screening
- Women of childbearing potential must agree to use effective contraception from 28 days before treatment to 1 year after infusion
- Male partners of fertile women must use effective barrier contraception from treatment start until 1 year after infusion
- Women of childbearing potential must have a negative pregnancy test within 48 hours before screening
- Prior treatment with glucocorticoids and immunosuppressants and/or biologics for at least 3 months with stable doses for 2 weeks, with active disease
- Oral steroids at prednisone ≥ 7.5 mg/day if used alone; no minimum if combined with immunosuppressants or biologics
- Positive anti-nuclear antibodies, anti-dsDNA, and/or anti-Smith antibodies at screening
- SLEDAI-2K score ≥ 7 or significant organ dysfunction including severe immune thrombocytopenia or active lupus nephritis
- Active involvement of organs such as kidneys, heart, lungs, musculoskeletal system, blood, or vessels; skin/mucosal involvement alone not eligible
- Adequate organ function including renal, bone marrow, liver, coagulation, pulmonary, and cardiac measures as defined
You will not qualify if you...
- Severe lupus nephritis requiring hemodialysis or prednisone ≥ 100 mg/day for ≥ 14 days within 2 months before screening
- Plasma exchange, plasma separation, or hemodialysis within 30 days prior to screening, or lupus crisis within 30 days
- History of grade ≥ 2 bleeding or need for long-term anticoagulation within 30 days
- Recent major cardiovascular events or severe heart conditions within 30 days before screening
- Prior central nervous system lupus manifestations or pre-existing CNS diseases
- Active systemic infections including tuberculosis within 2 weeks of screening
- Prior CAR-T or genetically modified T cell therapy or major organ/hematopoietic stem cell transplant history
- Allergic or intolerant reactions to study drugs or components including severe allergies
- Use of B cell-targeting drugs within 6 months or other biologics within 12 weeks prior to screening
- Prednisone ≥ 10 mg/day within 2 weeks prior to infusion, except for physiological, topical, or inhaled steroids
- Use of T cell-affecting immunosuppressants or JAK inhibitors within 2 weeks prior to infusion
- Vaccination with live, inactivated, or RNA vaccines within 1 month before screening
- Malignant tumors within 2 years except certain treated skin, prostate, cervical, or breast cancers
- Major surgery within 4 weeks before consent or planned during study posing unacceptable risk
- Active HIV, syphilis, hepatitis B or C infections during screening
- Participation in other clinical studies within 3 months or within five half-lives of last medication
- Uncontrolled major chronic diseases increasing participant risk
- History or evidence of significant suicidal thoughts or behavior
- Pregnant or breastfeeding women
- Poor compliance or inability to follow study protocol as assessed by researchers
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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