Actively Recruiting
CT1190B in the Treatment of Patients With Moderate to Severe Refractory Systemic Lupus Erythematosus (SLE) or Refractory/Progressive Systemic Sclerosis (SSc)
Led by Beijing GoBroad Hospital · Updated on 2026-03-10
27
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
Sponsors
B
Beijing GoBroad Hospital
Lead Sponsor
C
CARsgen Therapeutics Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Clinical Study Exploring CT1190B in the treatment of patients with moderate to severe refractory systemic lupus erythematosus (SLE) or refractory/progressive systemic sclerosis (SSc)
CONDITIONS
Official Title
CT1190B in the Treatment of Patients With Moderate to Severe Refractory Systemic Lupus Erythematosus (SLE) or Refractory/Progressive Systemic Sclerosis (SSc)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed the Informed Consent Form
- Age between 18 and 60 years old at the time of consent
- No systemic active infection within 2 weeks before screening
- Contraceptive use for participants with child-bearing potential
- Negative pregnancy test for women with child-bearing potential
- For SLE: Meet 2019 EULAR/ACR SLE criteria with disease history of at least 6 months
- For SLE: Treated with glucocorticoids plus immunosuppressive agents or biological agents for 3 months with stable dose for 2 weeks and active disease
- For SLE: Oral corticosteroid dose at screening at least 7.5 mg/day prednisone if corticosteroids alone
- For SLE: Positive antibody test (antinuclear, anti-ds-DNA, or anti-Smith)
- For SLE: SLEDAI-2K score of 7 or higher at screening
- For SLE: Active organ involvement excluding isolated skin and mucous membrane
- For SLE: Adequate organ function including renal, bone marrow, liver, coagulation, lung, and cardiac function
- For SSc: Meet 2013 EULAR/ACR systemic sclerosis criteria with diffuse-type manifestation
- For SSc: Presence of interstitial pneumonia caused by SSc
- For SSc: Refractory or progressive disease as defined by treatment response and progression criteria
- For SSc: Adequate organ function including renal, bone marrow, liver, coagulation, and cardiac function
You will not qualify if you...
- Previous CAR-T or genetically modified T-cell therapy or major organ transplantation
- Use of B-cell targeted drugs within 2 months before screening
- Allergy or intolerance to lymphodepletion drugs, tocilizumab, CT1190B, or severe allergies
- Use of corticosteroids ≥10 mg/day prednisone within 10 days before CT1190B infusion
- Use of immunosuppressive agents affecting T-cells within 10 days before CT1190B infusion
- Use of JAK inhibitors within 3 days before CT1190B infusion
- Vaccination with live-attenuated, inactivated, or RNA vaccines within 1 month before screening
- Cancer diagnosis within 2 years before consent with some exceptions
- Major surgery within 4 weeks before consent or planned during study posing risk
- Positive test for HIV, syphilis, active hepatitis B or C at screening
- History of central nervous system diseases including stroke, epilepsy, dementia, or mental illness
- Significant cardiovascular disease within 1 month before screening
- Participation in other clinical studies within 3 months before screening
- Presence of uncontrolled active infections including tuberculosis
- History or evidence of suicidal thoughts or behavior within specified timeframes
- Pregnant or breastfeeding women
- Poor compliance or inability to follow study protocol
- For SLE: Severe lupus nephritis in past 2 months or lupus crisis in past month
- For SLE: Central nervous system lupus manifestations or recent bleeding or plasmapheresis
- For SSc: Very low lung function or severe kidney disease or renal crisis
- For SSc: Risk of active tuberculosis at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China, 102200
Actively Recruiting
Research Team
J
Jing Pan
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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