Safety, Efficacy and Cellular Metabolic Dynamics of CT1195E in Patients With Refractory / Progressive SSC

NCT07355972 | Recruiting Early Phase 1

• 1 other identifier: CT1195E-CG11010
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

SSc-Systemic Sclerosis

Outcome Measures

Primary Outcomes (5)

• The maximum tolerable dose (MTD) and / or dose range of CT1195E were evaluated

  CT1195E MTD and/or dose range

  After medication to day 28

• severity of dose limiting toxicity (DLT)

  Within 28 days after infusion

• severity of adverse events (AES)

  Within 180 days after infusion

• Incidence of adverse events (AES)

  Within 180 days after infusion

• Incidence of dose limiting toxicity (DLT)

  Within 28 days after infusion

Secondary Outcomes (18)

• Changes of systemic sclerosis comprehensive response index score (acr-criss) from baseline

  2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)

• Changes from baseline in scleroderma clinical trials Association injury index (sctc-di)

  2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)

• Changes from baseline in modified Rodnan skin scale (MRSS)

  2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)

• Changes in lung function (FVC) from baseline

  2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)

• Changes from baseline in left ventricular ejection fraction (LVEF) by cardiac function tests

  2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)

Study Arms (1)

CT1195E CAR-T cells Injection

EXPERIMENTAL

CT1195E cells infusion

Other: CAR-T Therapy

Interventions

CAR-T Therapy OTHER

CT1195E cells infusion

CT1195E CAR-T cells Injection

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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):
• Aggravation of symptoms;
• FVC estimated value decreases by 5%, or DLCO estimated value decreases by 10%;
• Pulmonary imaging aggravated;
• important organ functions:
• Renal function: defined as creatinine clearance (Cockcroft Gault) ≥ 50 ml/min calculated without hydration assistance;

You may not qualify if:

• 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;
• suffering from malignant tumor within 2 years before signing ICF. Except for the following cases: non melanoma skin cancer after radical treatment, local prostate cancer, cervical carcinoma in situ confirmed by biopsy or squamous intraepithelial lesions detected by cervical smear, and breast carcinoma in situ that has been completely removed;
• major surgery has been performed within 4 weeks before signing the informed consent, or major surgery is planned to be required during the study, which the investigator believes will bring unacceptable risks to the study participants;
• HIV, syphilis infection, active hepatitis B virus infection (HBsAg positive and HBV-DNA above the detection limit), or active hepatitis C virus infection (HCV antibody and HCV-RNA positive) were present at the time of screening;
• those with CNS diseases before screening include but are not limited to: cerebrovascular accident, encephalitis, epilepsy, convulsion / convulsion, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, CNS vasculitis, cognitive dysfunction, cerebral organic syndrome or psychosis;
• have a history of any of the following cardiovascular diseases within 1 month before screening: Grade III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia or other heart disease with significant clinical significance as defined by the New York Heart Association (NYHA);

Sponsors & Collaborators

• CARsgen Therapeutics Co., Ltd.: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Wuhan Union Hospita

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Interventions

Immunotherapy, Adoptive

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Central Study Contacts

Qiubai Li

CONTACT

Professor 85726808 Ext.027; qiubaili@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Department of Rheumatology and Immunology, Principal Investigator, Professor, Wuhan Union Hospital

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: January 21, 2026
• Study Start: January 16, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 21, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)