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.
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;
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;
Single group
CAR-T Therapy
Other interventionCT1195E cells infusion
The maximum tolerable dose (MTD) and / or dose range of CT1195E were evaluated
CT1195E MTD and/or dose range
severity of dose limiting toxicity (DLT)
severity of adverse events (AES)
Incidence of adverse events (AES)
Changes of systemic sclerosis comprehensive response index score (acr-criss) from baseline
The score range of the comprehensive response index for systemic sclerosis (acr-criss) is usually 0 to 100, where 0 represents the lowest disease activity and burden, and 100 represents the highest. The higher the score, the higher the disease activity, severity of skin involvement or overall disease burden of systemic sclerosis.
Changes from baseline in scleroderma clinical trials Association injury index (sctc-di)
The minimum value of scleroderma clinical trials Association injury index (sctc-di) is 0 and the maximum value is 42. The higher the score, the more serious the organ damage, that is, the worse the result.
Changes from baseline in modified Rodnan skin scale (MRSS)
The minimum value of the modified Rodnan skin scale (MRSS) is 0 points, and the maximum value is 57 points. The higher the score, the more severe the degree of skin sclerosis, that is, the worse the result. MRSS quantifies the skin involvement of systemic sclerosis by evaluating the skin hardness of 19 parts of the body. 0 points represent normal skin and 3 points represent severe thickening. The higher the total score, the more extensive and severe skin fibrosis, which is associated with disease activity and poor prognosis.
Changes in lung function (FVC) from baseline
The normal value of FVC in healthy adults usually ranges from 3 to 5 liters, and the specific value varies according to age, sex, height, race and other factors. Higher FVC values usually indicate better lung function, because higher FVC means greater lung volume and stronger respiratory muscle strength.
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
CARsgen Therapeutics Co., Ltd.
Collaborator
