Actively Recruiting
Safety, Efficacy and Cellular Metabolic Dynamics of CT1195E in Patients With Refractory / Progressive SSC
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2026-01-21
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 label, exploratory dose escalation clinical study to evaluate the safety, efficacy, and cellular metabolic dynamics of ct1195e cells in patients with SSc. The study was divided into dose escalation phase and dose expansion phase.
CONDITIONS
Official Title
Safety, Efficacy and Cellular Metabolic Dynamics of CT1195E in Patients With Refractory / Progressive SSC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent and able to complete all study procedures
- Age between 18 and 60 years old at consent, any gender
- No active systemic infection within 2 weeks before screening
- Women capable of conceiving must use effective contraception from 28 days before treatment to 1 year after infusion and test negative for pregnancy at screening
- Men with fertile partners must use effective barrier contraception from treatment start to 1 year after infusion
- Meet 2013 EULAR/ACR classification for systemic sclerosis with diffuse manifestations and disease duration of 7 years or less
- Have interstitial pneumonia shown as ground glass changes on chest HRCT
- Disease is refractory (no response to conventional treatment over 6 months or relapse after remission) or progressive (meeting at least 2 of 3 specified worsening criteria in past year)
- Adequate organ function including renal (creatinine clearance ≥ 50 ml/min), bone marrow (ANC ≥ 1.0×10^9/L, hemoglobin ≥ 90 g/L), liver (ALT and AST ≤ 2× ULN, bilirubin ≤ 2× ULN), coagulation (INR and PT ≤ 1.5× ULN), and cardiac function (LVEF ≥ 40%)
You will not qualify if you...
- Forced vital capacity (FVC) ≤ 30% predicted or DLCO ≤ 30% predicted
- Severe kidney disease or signs of renal crisis
- Signs or history of active tuberculosis or risk of active tuberculosis
- Prior CAR-T or gene-modified T cell therapy or major organ or bone marrow transplantation
- Use of B cell targeting drugs (e.g., rituximab) within 3 months before screening
- Allergic or intolerant to study drug or excipients
- Use of prednisone ≥ 10 mg/day within 2 weeks before infusion (except physiological, local, inhaled steroids)
- Use of immunosuppressants affecting T cells within 2 weeks before infusion
- Use of JAK inhibitors within 2 weeks before infusion
- Vaccination with live, inactivated, or RNA vaccines within 1 month before screening
- Malignant tumor within 2 years except certain treated localized cancers
- Major surgery within 4 weeks before consent or planned during study posing unacceptable risks
- HIV, syphilis, active hepatitis B or C infection at screening
- CNS diseases including stroke, epilepsy, dementia, or psychosis
- Recent serious cardiovascular diseases within 1 month
- Participation in other clinical trials within 3 months or within five half-lives of last medication
- Uncontrollable active infection
- Recent suicidal thoughts or behavior
- 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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