SSc-Systemic SclerosisEarly Phase 1NCT07355972
Safety, Efficacy and Cellular Metabolic Dynamics of CT1195E in Patients With Refractory / Progressive SSC
A Early Phase 1 study testing CAR-T Therapy in people with SSc-Systemic Sclerosis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- SSc-Systemic Sclerosis
- What is being tested?
- CAR-T Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 16 Jan 2026to 31 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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);
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- 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;
- Bone marrow function: defined as neutrophil (ANC) ≥ 1.0 × 109/l, hemoglobin (HB) ≥ 90 g/l. Blood transfusion and growth factors shall not be used to meet the above requirements within 7 days before the eligibility screening;
- Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 × upper limit of normal (ULN), total bilirubin ≤ 2 × upper limit of normal (ULN)
- Coagulation function: INR ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN;
- Cardiac function: good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥ 40%.
Who cannot join
- 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;
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- 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);
- participate in other clinical studies within 3 months before screening or still within five half lives after the last medication.
- there is currently any uncontrollable active infection, including but not limited to active tuberculosis;
- if there is a history of suicidal thoughts or evidence within 6 months before signing the ICF, or any suicidal behavior within 12 months before signing the ICF, the investigator believes that there is a significant risk of suicide;
- pregnant or lactating women;
- the investigator judged that the study participants had poor compliance, were unable or unwilling to comply with the requirements of the study protocol, or were not suitable to participate in the clinical study for other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Clinical Study Exploring the Safety, Efficacy and Cellular Metabolic Dynamics of CT1195E Car-t Cell Injection in Refractory / Progressive Systemic Sclerosis (SSC)
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
- Being tested
- CAR-T Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T TherapyOther
CT1195E cells infusion
| Study group | Role | What they receive |
|---|---|---|
| CT1195E CAR-T cells Injection | Experimental | CT1195E cells infusion Receives: Other: CAR-T Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum tolerable dose (MTD) and / or dose range of CT1195E were evaluated
CT1195E MTD and/or dose range
Measured: After medication to day 28
severity of dose limiting toxicity (DLT)
Measured: Within 28 days after infusion
severity of adverse events (AES)
Measured: Within 180 days after infusion
Incidence of adverse events (AES)
Measured: Within 180 days after infusion
Incidence of dose limiting toxicity (DLT)
Measured: Within 28 days after infusion
Secondary outcomes (18)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)
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.
Measured: 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
Measured: 2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)
Changes of joint disease activity score (DAS-28) (if joint involvement) from baseline
The minimum value of joint disease activity score (DAS-28) is 0 and the maximum value is 10. The higher the score, the higher the disease activity, that is, the worse the result, because the score is used to measure the activity of joint inflammation, and the increase of the score reflects the enhanced disease activity.
Measured: 2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)
Changes of inflammation related indicators (CRP or ESR) from baseline
Measured: 2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)
SSC specific antibodies (changes in anti-Scl-70 antibody levels from baseline
Measured: 2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)
Changes of anti RNA polymerase III antibody [rp155, rp11] levels from baseline
Measured: 2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)
Immune related autoantibodies (antinuclear antibody ANA) levels and changes from baseline
Measured: 2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)
Proportion of patients without other SSC therapies after medication
Measured: 2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)
Vascular lesions were assessed by nailfold capillary microscopy after medication
Measured: 2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)
Skin elasticity was assessed by skin ultrasound after medication
Measured: 2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)
Changes of chest HRCT in study participants after medication evaluation
Measured: 2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)
Change from baseline in the post medication Health Assessment Questionnaire Disability Index (HAQ-DI)
The score range of the Health Assessment Questionnaire Disability Index (HAQ-DI) is usually 0 to 3, where 0 represents no disability or functional integrity, and 3 represents severe disability or inability to complete activities. The higher the score, the worse the patient's functional status, because HAQ-DI quantifies the degree of disability by evaluating the ability of daily activities, for example, the increased score in items such as dressing and walking reflects the increased difficulty.
Measured: 2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)
The level of CT1195e transgene copy number in blood
Measured: Within 1 year after CAR-T cell infusion
Changes of B cell functional subsets (initial B cells, memory B cells, plasma cells) after ct1195E infusion
Measured: Within 1 year after CAR-T cell infusion
Duration of ct1195e transgene copy number in blood
Measured: Within 1 year after CAR-T cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start16 Jan 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SSc-Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- CARsgen Therapeutics Co., Ltd.
- Responsible party
- Principal investigator, Qiubai Li, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355972
- Sponsor's protocol ID
- CT1195E-CG11010
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Exploring the Safety, Efficacy and Cellular Metabolic Dynamics of CT1195E Car-t Cell Injection in Refractory / Progressive Systemic Sclerosis (SSC)
- ClinicalTrials.gov ID
- NCT07355972
- Acronym / sponsor ID
- CT1195E-CG11010
- Conditions
- SSc-Systemic Sclerosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- CARsgen Therapeutics Co., Ltd.
- Study start
- 16 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT1195E CAR-T cells Injection | Experimental | Other: CAR-T TherapyCT1195E cells infusion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAR-T TherapyCT1195E cells infusion | Other | CT1195E CAR-T cells Injection |
Primary outcome
The maximum tolerable dose (MTD) and / or dose range of CT1195E were evaluated
Time frame: After medication to day 28
CT1195E MTD and/or dose range
severity of dose limiting toxicity (DLT)
Time frame: Within 28 days after infusion
severity of adverse events (AES)
Time frame: Within 180 days after infusion
Incidence of adverse events (AES)
Time frame: Within 180 days after infusion
Incidence of dose limiting toxicity (DLT)
Time frame: Within 28 days after infusion
18 secondary outcomes
Changes of systemic sclerosis comprehensive response index score (acr-criss) from baseline
Time frame: 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)
Time frame: 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)
Time frame: 2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)
Changes in lung function (FVC) from baseline
Time frame: 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
Time frame: 2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)
Changes of joint disease activity score (DAS-28) (if joint involvement) from baseline
Time frame: 2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)
Changes of inflammation related indicators (CRP or ESR) from baseline
Time frame: 2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)
SSC specific antibodies (changes in anti-Scl-70 antibody levels from baseline
Time frame: 2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)
Changes of anti RNA polymerase III antibody [rp155, rp11] levels from baseline
Time frame: 2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)
Immune related autoantibodies (antinuclear antibody ANA) levels and changes from baseline
Time frame: 2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)
Proportion of patients without other SSC therapies after medication
Time frame: 2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)
Vascular lesions were assessed by nailfold capillary microscopy after medication
Time frame: 2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)
Skin elasticity was assessed by skin ultrasound after medication
Time frame: 2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)
Changes of chest HRCT in study participants after medication evaluation
Time frame: 2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)
Change from baseline in the post medication Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: 2 months and other time points after medication (the 1st, 3st, 6th, 9th and 12th months)
The level of CT1195e transgene copy number in blood
Time frame: Within 1 year after CAR-T cell infusion
Changes of B cell functional subsets (initial B cells, memory B cells, plasma cells) after ct1195E infusion
Time frame: Within 1 year after CAR-T cell infusion
Duration of ct1195e transgene copy number in blood
Time frame: Within 1 year after CAR-T cell infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CAR-T Therapy in people with SSc-Systemic Sclerosis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiubai Li (Professor 85726808 Ext.027, qiubaili@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum tolerable dose (MTD) and / or dose range of CT1195E were evaluated (time frame: After medication to day 28). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.