NCT07355972
招募中
早期 1 期
A Clinical Study Exploring the Safety, Efficacy and Cellular Metabolic Dynamics of CT1195E Car-t Cell Injection in Refractory / Progressive Systemic Sclerosis (SSC)
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology0 个研究点目标入组 12 人开始时间: 2026年1月16日最近更新:
概览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- 入组人数
- 12
概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •voluntarily sign the informed consent form (ICF): I fully understand and know this study and sign the informed consent form. I am willing to follow and be able to complete all research procedures;
- •when signing ICF, the age is between 18 and 60 years old (including 18 and 60 years old), regardless of gender;
- •no systemic active infection (such as infectious pneumonia and tuberculosis) within 2 weeks before screening;
- •women with fertility (defined as all women who are physically able to conceive) must agree to use efficient contraceptive methods from at least 28 days before the start of gonorrhea to 1 year after ct1195e infusion, and it is absolutely prohibited to donate eggs within 1 year after receiving study treatment infusion during the study period. Men whose partners are fertile must agree to use effective barrier contraception from the beginning of gonorrhea to 1 year after ct1195e infusion, and should not donate semen or sperm during the entire study period;
- •women with fertility must be tested negative for serum β human chorionic gonadotropin (β -hcg) at the time of screening and within 48 hours before gonorrhea treatment.
- •meet the 2013 eular/acr classification criteria for systemic sclerosis, and meet the diffuse manifestations, and the disease duration is ≤ 7 years (the onset time of the disease duration is defined as the time of the initial diagnosis of SSC);
- •complicated with interstitial pneumonia, that is, the interstitial changes of ground glass exudation suggested by chest HRCT;
- •meet the following definitions of refractory or progressive disease:
- •Definition of refractory: the conventional treatment for more than 6 months is still ineffective, or the disease relapses after remission. Definition of conventional treatment: use of glucocorticoids (more than 1 mg/kg/d) or cyclophosphamide, as well as one or more of the following immunomodulatory drugs: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents, including yamerol, rituximab, belizumab, etanercept, etc;
- •According to the definition of progressiveness, 2 of the following three items can be met in the past 1 year (within the past 1 year):
排除标准
- •FVC ≤ 30% predicted value or DLCO (corrected by hemoglobin) ≤ 30% predicted value;
- •study participants with severe kidney disease or signs of renal crisis;
- •there is active tuberculosis risk during screening: there are signs or symptoms of active tuberculosis judged by the investigator (such as fever, cough, night sweat and weight loss); Records of chest imaging (e.g., chest X-ray, chest CT scan) performed at screening or any time within 6 months before screening showed active tuberculosis.
- •have previously received car-t cell or other gene modified T cell therapy, or have a history of major organ transplantation (such as heart, lung, kidney, liver) or hematopoietic stem cell / bone marrow transplantation;
- •have used drugs targeting B cells (such as rituximab) within 3 months before screening;
- •allergic or intolerant to Qinglin drugs and tocilizumab, or life-threatening allergic reaction, hypersensitivity reaction or intolerance to ct1195e preparation or its excipients (including dimethyl sulfoxide (DMSO), or previous history of other serious allergies such as allergic shock;
- •prednisone (≥ 10 mg / day) (or equivalent drug) is used for hormones within 2 weeks before ct1195e infusion, and physiological replacement, local and inhalation hormones are allowed;
- •received immunosuppressants affecting T cells (mycophenolate mofetil, methotrexate, cyclosporine, azathioprine, leflunomide, tacrolimus) within 2 weeks before infusion of ct1195e;
- •received JAK inhibitors (tofacitinib, baricitinib tablets, lucotinib, etc.) within 2 weeks before ct1195e infusion;
- •have been vaccinated with live attenuated vaccine, inactivated vaccine or RNA vaccine within 1 month before screening;
研究者
Qiubai Li
Director, Head of Department of Rheumatology and Immunology, Principal Investigator, Professor, Wuhan Union Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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