Systemic Sclerosis (SSc)Early Phase 1NCT07072884
GC012F in Patients With Autoimmune Diseases
A Early Phase 1 study testing GC012F injection in people with Systemic Sclerosis (SSc) and Idiopathic Inflammatory Myopathy (IIM), run by Qiong Fu.
Trial summary
This is an open-label, early exploratory main clinical study to evaluate the safety and efficacy of GC012F Injection in subjects with autoimmune diseases (AID), as well as to assess its pharmacokinetic (PK) and pharmacodynamic (PD) profiles. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Sclerosis (SSc), Idiopathic Inflammatory Myopathy (IIM)
- What is being tested?
- GC012F injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 18 Aug 2025to 31 Mar 2029
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Only subjects who meet all of the following inclusion criteria prior to enrollment are eligible for this study. In addition, subjects should meet the relevant inclusion criteria for each indication as specified in the corresponding section of each sub-study protocol.
- The subject or legal representative voluntarily signs the written informed consent form (ICF) personally, and is willing and able to comply with study procedures;
- Aged 18 to 70 years (inclusive) at the time of signing the informed consent form, male or female;
- Willing to adhere to study-specific contraception requirements until 2 years after infusion or until two consecutive flow cytometry tests indicate that CAR-T cells are no longer present in females of childbearing potential and male subjects (whichever occurs later);
- Screening laboratory test results must meet the following criteria (except for indicators related to the diseases under study):
- Neutrophil count ≥ 1.0 × 10^9/L; hemoglobin ≥ 80 g/L; platelet count ≥ 50 × 10^9/L;
Show all 15Show fewer
- Alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); aspartate aminotransferase (AST) ≤ 3 × ULN (unless ALT and/or AST increase is assessed by the investigator as related to IIM); total bilirubin < 2 × ULN (for subjects with Gilbert's syndrome, direct bilirubin ≤ 1.5 × ULN);
- Creatinine clearance ≥ 60 mL/min, or estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73 m^2;
- Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, and prothrombin time (PT) ≤ 1.5 × ULN;
- Left ventricular ejection fraction (LVEF) ≥ 50% as determined by echocardiogram, with no evidence of pericardial effusion.
- Women of childbearing potential must:
- Have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result at screening as confirmed by the investigator;
- Agree to avoid breastfeeding during the study period and until at least 2 years after infusion of GC012F Injection, or until two consecutive flow cytometry tests indicate that CAR-T cells are no longer present (whichever occurs later).
- Male subjects with sexual partners and female subjects of childbearing potential must agree to use highly effective contraception methods (e.g., oral contraceptives, intrauterine devices, or condoms) starting from screening and continuing for at least 2 years after GC012F Injection infusion or until two consecutive flow cytometry tests indicate that CAR-T cells are no longer present (whichever occurs later). Male subjects must agree to use condoms during any sexual contact with pregnant women or women of childbearing potential for at least 2 years after GC012F Injection infusion, even if they have undergone successful vasoligation.
- The required venous access for collection can be set up, with no contraindications for leukapheresis.
Who cannot join
- Subjects who meet any of the following criteria are not eligible for the study. In addition, subjects who meet the relevant exclusion criteria for each indication as specified in the corresponding section of each sub-study protocol must not be enrolled.
- History of severe hypersensitivity or allergy;
- Contraindications or hypersensitivity to fludarabine, cyclophosphamide, or any component of the investigational product;
- Presence of the following cardiac disorders:
- New York Heart Association (NYHA) Class III or IV congestive heart failure;
- Myocardial infarction or coronary artery bypass grafting within 6 months prior to screening;
Show all 30Show fewer
- History of clinically significant ventricular arrhythmia or unexplained syncope not caused by vasovagal reactions or dehydration, or corrected QT interval > 480 ms at screening;
- History of severe non-ischemic cardiomyopathy.
- Any active malignancy or history of malignancy within 5 years prior to screening. The following are exceptions: early-stage tumors that have received curative treatment (carcinoma in situ or stage I tumors, non-ulcerative primary melanoma with a depth < 1 mm and no lymph node involvement), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, thyroid carcinoma in situ or early-stage thyroid cancer that has received curative treatment, cervical carcinoma in situ, or breast cancer in situ that has received potentially curative treatment;
- Clinically significant hemorrhage symptoms or a definite tendency to hemorrhage within 6 months prior to screening, such as hemorrhage of digestive tract and hemorrhagic gastric ulcer; hereditary or acquired hemorrhage or thrombotic tendencies (e.g., hemophilia, coagulation disorders, and hypersplenism); arterial or venous thrombotic events within 6 months prior to screening, such as cerebrovascular diseases (including cerebral hemorrhage and cerebral infarction), deep vein thrombosis and/or pulmonary embolism;
- Any of the following test results is positive:
- Human immunodeficiency virus (HIV) antibody positive;
- Hepatitis B surface antigen (HBsAg) positive; or hepatitis B core antibody (HBcAb) positive with hepatitis B virus deoxyribonucleic acid (DNA) above the lower limit of detection of the assay;
- Hepatitis C virus (HCV) antibody positive with HCV ribonucleic acid (RNA) above the lower limit of detection of the assay;
- Syphilis antibody positive (confirmation by a confirmatory test for syphilis is required if necessary, such as fluorescent treponemal antibody-absorption test and Treponema pallidum particle agglutination assay).
- Active tuberculosis or latent tuberculosis that has not received appropriate treatment prior to screening;
- Severe underlying medical conditions, such as:
- Evidence of viral, bacterial, fungal, or other infections that are uncontrolled or need systemic intravenous treatment;
- Clear clinical evidence of dementia or altered mental status;
- Any other central nervous system disease or history of neurodegenerative diseases, such as epilepsy, seizure, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, and psychosis.
- Prior therapy targeting cluster of differentiation (CD)19 and/or B-cell maturation antigen, or CAR-T product therapy targeting any antigen;
- Thymectomy within 12 months prior to signing the ICF;
- Treatment with CD20-targeted agents within 6 months prior to signing the ICF;
- Receipt of other investigational products within 4 weeks prior to signing the ICF, or if the time from the last dose of a previous investigational product to the ICF signing date is still within 5 half-lives of that drug (whichever is longer);
- Receipt of other monoclonal antibody drugs (e.g., infliximab, certolizumab pegol, golimumab, etanercept, abatacept, adalimumab, or tocilizumab) within 4 weeks prior to apheresis;
- Receipt of cyclophosphamide within 4 weeks prior to apheresis;
- Major surgery within 8 weeks prior to signing the ICF, or planned surgery during the study;
- History of organ transplantation;
- Pregnant women, breastfeeding women who do not agree to discontinue breastfeeding, or males and females who plan to conceive during the study or within 2 years after receiving study treatment;
- Any condition, as determined by the investigator, that would interfere with the subject's full participation in the study, confound the study results, or render participation in the study not in the best interest of the subject.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-Label Study to Assess the Safety and Efficacy of GC012F in Patients With Autoimmune Diseases
This is an open-label, early exploratory main clinical study to evaluate the safety and efficacy of GC012F Injection in subjects with autoimmune diseases (AID), as well as to assess its pharmacokinetic (PK) and pharmacodynamic (PD) profiles.
Read the detailed description
This study consists of the following periods: screening period, apheresis day, baseline period, lymphodepleting preconditioning period, GC012F infusion, safety and efficacy follow-up period, and long-term follow-up period.
Eligible subjects will undergo apheresis and will receive the infusion following the manufacture of the chimeric antigen receptor T cell (CAR-T) product. Prior to CAR-T cell infusion, subjects will receive lymphodepleting preconditioning and will be assessed before infusion. Subjects who meet the criteria for cell infusion will receive CAR-T cell infusion, and the infusion dose for the same group or subsequent study groups may be adjusted based on safety and clinical efficacy. In this study, the CAR-T cell infusion dose is set as follows: one target dose group (Dose Group 1): 3.0×10^5 CAR-T cells/kg, and one alternative dose group (Dose Group -1): 2.0×10^5 CAR-T cells/kg or 1.0×10^5 CAR-T cells/kg, with a total of 15 evaluable subjects to be enrolled. Among them, 6 subjects will be enrolled during the dose-limiting toxicity (DLT) observation stage, and 9 subjects will be enrolled during the expansion stage. This study does not establish separate cohorts for different indications (systemic sclerosis [SSc] or idiopathic inflammatory myopathies [IIM]). Eligible subjects will receive a single infusion of GC012F Injection. After all 6 subjects in the DLT observation stage have completed DLT observation, all clinical study data collected during the DLT observation stage (primarily safety data) will be assessed. If no more than 1 out of the 6 subjects experiences a DLT, 9 additional subjects will be enrolled in the dose expansion stage. If 2 subjects experience a DLT, the investigators and partner will discuss and decide whether to explore a lower dose group (Dose Group -1).
After CAR-T cell infusion, subjects will be followed up for safety, cellular expansion and persistence, and efficacy until 672 days (96 weeks) after infusion, or until the subject withdraws from the study and declines further follow-up, death, withdrawal of informed consent, or loss to follow-up, whichever occurs first.
Leukapheresis: Only subjects who have completed screening and fully meet the eligibility criteria may be enrolled. Mononuclear cells will be collected from the enrolled subjects and transported to a Good Manufacturing Practice (GMP)-compliant manufacturing workshop for cell preparation.
Lymphodepleting preconditioning: After confirming that the cells have passed quality control and met the release criteria, the investigator will determine whether to initiate lymphodepleting preconditioning based on the subject's condition on Day -5 prior to GC012F Injection infusion. The preconditioning will last for a total of 3 days (Days -5, -4, and -3 or Days -4, -3, and -2). The recommended preconditioning regimen is as follows:
- Fludarabine 30 mg/m^2/day, via intravenous infusion for 3 days;
- Cyclophosphamide 300 mg/m^2/day, via intravenous infusion for 3 days. GC012F Injection infusion: Subjects who meet the CAR-T cell infusion criteria will receive GC012F Injection infusion within 48-72 hours after completion of lymphodepleting preconditioning.
Safety and efficacy follow-up: Subjects who receive GC012F Injection infusion should continue with all subsequent post-infusion assessments.
The inpatient observation period should start from the infusion (Day 0) and continue for 14 days; hospitalization from Day 15 to Day 28 should follow local diagnosis and treatment guidelines. The window for the Day 4, Day 7 (Week 1), Day 10, and Day 14 (Week 2) visits is ±1 day; for the Day 28 (Week 4) visit, the window is +3 days. Within 12 weeks after GC012F Injection infusion, follow-up visits will be conducted every 28 days (4 weeks) ±7 days (1 week). From Weeks 12 to 48, follow-up visits will be conducted every 84 days (12 weeks) ±7 days (1 week). After Week 48, follow-up visits will be conducted every 6 months (24 weeks) ±14 days (2 weeks), until 672 days (96 weeks) after infusion, withdrawal of informed consent, withdrawal from the study with refusal to undergo subsequent follow-up, death, or loss to follow-up, whichever occurs first. Subjects who do not withdraw from the study prematurely within 672 days (96 weeks) will proceed to the long-term follow-up period. The end of this study is defined as 672 days (96 weeks) after the last GC012F Injection infusion to the last subject.
Long-term follow-up: Subjects who do not withdraw from the study prematurely within 672 days (96 weeks) after infusion will proceed to the long-term follow-up period, which will continue until withdrawal of informed consent, withdrawal from the study with refusal to undergo subsequent follow-up, death, loss to follow-up, or 15 years after cell infusion, whichever occurs first. During this period, the primary focus will be on the collection of serious adverse events related to GC012F Injection. From Years 3 to 5 post-infusion, subjects will undergo follow-up every six months for replication competent lentivirus (RCL) and lentiviral integration site testing, and disease assessment-related examinations. From Years 6 to 15 post-infusion, subjects are required to undergo annual follow-up for RCL testing, lentiviral vector integration site testing, and disease assessment-related examinations.
Withdrawal visit: Subjects who withdraw from the study will undergo a withdrawal visit as specified. If a subject has initiated a new treatment prior to the withdrawal visit, details regarding the diagnostic basis for disease activity and the treatment process should be documented in chronological order unless the subject withdraws consent. There is no need to repeat the efficacy assessment at the withdrawal visit if it occurs within 4 weeks after the last two consecutive efficacy assessments. Other assessments do not need to be repeated if they are conducted within 2 weeks after the last assessment.
- Being tested
- GC012F injection
- Medical subject headings
- Scleroderma, Systemic, Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC012F injectionDrug
Subjects who meet the CAR-T cell infusion criteria will receive GC012F Injection infusion within 48-72 hours after completion of lymphodepleting preconditioning.
| Study group | Role | What they receive |
|---|---|---|
| 3.0×10^5 CAR-T cells/kg | Experimental | Not described Receives: Drug: GC012F injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with dose-limiting toxicity (DLT) within 28 days after infusion.
Measured: 28 days after infusion.
Post-infusion adverse events and their proportion.
Measured: From the signing of informed consent through 672 days (96 weeks) after cell infusion or initiation of a new therapy, whichever occurs first.
Secondary outcomes (6)
Chimeric antigen receptor T cell (CAR-T) levels in peripheral blood at each time point.
Measured: From the signing of informed consent through 672 days (96 weeks) after cell infusion or initiation of a new therapy, whichever occurs first.
Chimeric antigen receptor transgene levels in peripheral blood at each time point.
Measured: From the signing of informed consent through 672 days (96 weeks) after cell infusion or initiation of a new therapy, whichever occurs first.
Quantification of cytokines in peripheral blood at each time point.
Measured: From the signing of informed consent through 672 days (96 weeks) after cell infusion or initiation of a new therapy, whichever occurs first.
Quantification of immunoglobulins in peripheral blood at each time point.
Measured: From the signing of informed consent through 672 days (96 weeks) after cell infusion or initiation of a new therapy, whichever occurs first.
Changes in patient reported outcomes (PROs) from baseline at each time point: health assessment questionnaire disability index (HAQ-DI) .
Measured: From the signing of informed consent through 672 days (96 weeks) after cell infusion or initiation of a new therapy, whichever occurs first.
Changes in patient reported outcomes (PROs) from baseline at each time point: patient global activity assessment (PtGA).
Measured: From the signing of informed consent through 672 days (96 weeks) after cell infusion or initiation of a new therapy, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start18 Aug 2025 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Sclerosis (SSc)Studies of the same condition, open and under way.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qiong Fu
- Sponsor type
- University, hospital or other
- Collaborators
- Gracell Biotechnologies (Shanghai) Co., Ltd.
- Responsible party
- Sponsor-investigator, Qiong Fu, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072884
- Sponsor's protocol ID
- 24105/D8318N00001
- Status last verified
- Mar 2025
- First submitted
- 18 Jun 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Assess the Safety and Efficacy of GC012F in Patients With Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT07072884
- Acronym / sponsor ID
- 24105/D8318N00001
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Qiong FuUniversity, hospital or other
- Collaborators
- Gracell Biotechnologies (Shanghai) Co., Ltd.
- Study start
- 18 Aug 2025 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 18 Jul 2025 (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 is an open-label, early exploratory main clinical study to evaluate the safety and efficacy of GC012F Injection in subjects with autoimmune diseases (AID), as well as to assess its pharmacokinetic (PK) and pharmacodynamic (PD) profiles.
Detailed description
This study consists of the following periods: screening period, apheresis day, baseline period, lymphodepleting preconditioning period, GC012F infusion, safety and efficacy follow-up period, and long-term follow-up period.
Eligible subjects will undergo apheresis and will receive the infusion following the manufacture of the chimeric antigen receptor T cell (CAR-T) product. Prior to CAR-T cell infusion, subjects will receive lymphodepleting preconditioning and will be assessed before infusion. Subjects who meet the criteria for cell infusion will receive CAR-T cell infusion, and the infusion dose for the same group or subsequent study groups may be adjusted based on safety and clinical efficacy. In this study, the CAR-T cell infusion dose is set as follows: one target dose group (Dose Group 1): 3.0×10^5 CAR-T cells/kg, and one alternative dose group (Dose Group -1): 2.0×10^5 CAR-T cells/kg or 1.0×10^5 CAR-T cells/kg, with a total of 15 evaluable subjects to be enrolled. Among them, 6 subjects will be enrolled during the dose-limiting toxicity (DLT) observation stage, and 9 subjects will be enrolled during the expansion stage. This study does not establish separate cohorts for different indications (systemic sclerosis [SSc] or idiopathic inflammatory myopathies [IIM]). Eligible subjects will receive a single infusion of GC012F Injection. After all 6 subjects in the DLT observation stage have completed DLT observation, all clinical study data collected during the DLT observation stage (primarily safety data) will be assessed. If no more than 1 out of the 6 subjects experiences a DLT, 9 additional subjects will be enrolled in the dose expansion stage. If 2 subjects experience a DLT, the investigators and partner will discuss and decide whether to explore a lower dose group (Dose Group -1).
After CAR-T cell infusion, subjects will be followed up for safety, cellular expansion and persistence, and efficacy until 672 days (96 weeks) after infusion, or until the subject withdraws from the study and declines further follow-up, death, withdrawal of informed consent, or loss to follow-up, whichever occurs first.
Leukapheresis: Only subjects who have completed screening and fully meet the eligibility criteria may be enrolled. Mononuclear cells will be collected from the enrolled subjects and transported to a Good Manufacturing Practice (GMP)-compliant manufacturing workshop for cell preparation.
Lymphodepleting preconditioning: After confirming that the cells have passed quality control and met the release criteria, the investigator will determine whether to initiate lymphodepleting preconditioning based on the subject's condition on Day -5 prior to GC012F Injection infusion. The preconditioning will last for a total of 3 days (Days -5, -4, and -3 or Days -4, -3, and -2). The recommended preconditioning regimen is as follows:
- Fludarabine 30 mg/m^2/day, via intravenous infusion for 3 days;
- Cyclophosphamide 300 mg/m^2/day, via intravenous infusion for 3 days. GC012F Injection infusion: Subjects who meet the CAR-T cell infusion criteria will receive GC012F Injection infusion within 48-72 hours after completion of lymphodepleting preconditioning.
Safety and efficacy follow-up: Subjects who receive GC012F Injection infusion should continue with all subsequent post-infusion assessments.
The inpatient observation period should start from the infusion (Day 0) and continue for 14 days; hospitalization from Day 15 to Day 28 should follow local diagnosis and treatment guidelines. The window for the Day 4, Day 7 (Week 1), Day 10, and Day 14 (Week 2) visits is ±1 day; for the Day 28 (Week 4) visit, the window is +3 days. Within 12 weeks after GC012F Injection infusion, follow-up visits will be conducted every 28 days (4 weeks) ±7 days (1 week). From Weeks 12 to 48, follow-up visits will be conducted every 84 days (12 weeks) ±7 days (1 week). After Week 48, follow-up visits will be conducted every 6 months (24 weeks) ±14 days (2 weeks), until 672 days (96 weeks) after infusion, withdrawal of informed consent, withdrawal from the study with refusal to undergo subsequent follow-up, death, or loss to follow-up, whichever occurs first. Subjects who do not withdraw from the study prematurely within 672 days (96 weeks) will proceed to the long-term follow-up period. The end of this study is defined as 672 days (96 weeks) after the last GC012F Injection infusion to the last subject.
Long-term follow-up: Subjects who do not withdraw from the study prematurely within 672 days (96 weeks) after infusion will proceed to the long-term follow-up period, which will continue until withdrawal of informed consent, withdrawal from the study with refusal to undergo subsequent follow-up, death, loss to follow-up, or 15 years after cell infusion, whichever occurs first. During this period, the primary focus will be on the collection of serious adverse events related to GC012F Injection. From Years 3 to 5 post-infusion, subjects will undergo follow-up every six months for replication competent lentivirus (RCL) and lentiviral integration site testing, and disease assessment-related examinations. From Years 6 to 15 post-infusion, subjects are required to undergo annual follow-up for RCL testing, lentiviral vector integration site testing, and disease assessment-related examinations.
Withdrawal visit: Subjects who withdraw from the study will undergo a withdrawal visit as specified. If a subject has initiated a new treatment prior to the withdrawal visit, details regarding the diagnostic basis for disease activity and the treatment process should be documented in chronological order unless the subject withdraws consent. There is no need to repeat the efficacy assessment at the withdrawal visit if it occurs within 4 weeks after the last two consecutive efficacy assessments. Other assessments do not need to be repeated if they are conducted within 2 weeks after the last assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3.0×10^5 CAR-T cells/kg | Experimental | Drug: GC012F injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Only subjects who meet all of the following inclusion criteria prior to enrollment are eligible for this study. In addition, subjects should meet the relevant inclusion criteria for each indication as specified in the corresponding section of each sub-study protocol.
- The subject or legal representative voluntarily signs the written informed consent form (ICF) personally, and is willing and able to comply with study procedures;
- Aged 18 to 70 years (inclusive) at the time of signing the informed consent form, male or female;
- Willing to adhere to study-specific contraception requirements until 2 years after infusion or until two consecutive flow cytometry tests indicate that CAR-T cells are no longer present in females of childbearing potential and male subjects (whichever occurs later);
- Screening laboratory test results must meet the following criteria (except for indicators related to the diseases under study):
Key exclusion criteria (30 listed)
- Subjects who meet any of the following criteria are not eligible for the study. In addition, subjects who meet the relevant exclusion criteria for each indication as specified in the corresponding section of each sub-study protocol must not be enrolled.
- History of severe hypersensitivity or allergy;
- Contraindications or hypersensitivity to fludarabine, cyclophosphamide, or any component of the investigational product;
- Presence of the following cardiac disorders:
- Any active malignancy or history of malignancy within 5 years prior to screening. The following are exceptions: early-stage tumors that have received curative treatment (carcinoma in situ or stage I tumors, non-ulcerative primary melanoma with a depth < 1 mm and no lymph node involvement), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, thyroid carcinoma in situ or early-stage thyroid cancer that has received curative treatment, cervical carcinoma in situ, or breast cancer in situ that has received potentially curative treatment;
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 |
|---|---|---|
| GC012F injectionSubjects who meet the CAR-T cell infusion criteria will receive GC012F Injection infusion within 48-72 hours after completion of lymphodepleting preconditioning. | Drug | 3.0×10^5 CAR-T cells/kg |
Primary outcome
Proportion of subjects with dose-limiting toxicity (DLT) within 28 days after infusion.
Time frame: 28 days after infusion.
Post-infusion adverse events and their proportion.
Time frame: From the signing of informed consent through 672 days (96 weeks) after cell infusion or initiation of a new therapy, whichever occurs first.
6 secondary outcomes
Chimeric antigen receptor T cell (CAR-T) levels in peripheral blood at each time point.
Time frame: From the signing of informed consent through 672 days (96 weeks) after cell infusion or initiation of a new therapy, whichever occurs first.
Chimeric antigen receptor transgene levels in peripheral blood at each time point.
Time frame: From the signing of informed consent through 672 days (96 weeks) after cell infusion or initiation of a new therapy, whichever occurs first.
Quantification of cytokines in peripheral blood at each time point.
Time frame: From the signing of informed consent through 672 days (96 weeks) after cell infusion or initiation of a new therapy, whichever occurs first.
Quantification of immunoglobulins in peripheral blood at each time point.
Time frame: From the signing of informed consent through 672 days (96 weeks) after cell infusion or initiation of a new therapy, whichever occurs first.
Changes in patient reported outcomes (PROs) from baseline at each time point: health assessment questionnaire disability index (HAQ-DI) .
Time frame: From the signing of informed consent through 672 days (96 weeks) after cell infusion or initiation of a new therapy, whichever occurs first.
Changes in patient reported outcomes (PROs) from baseline at each time point: patient global activity assessment (PtGA).
Time frame: From the signing of informed consent through 672 days (96 weeks) after cell infusion or initiation of a new therapy, whichever occurs first.
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 18 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Systemic Sclerosis (SSc)
RecruitingObservational study
Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images
Systemic Sclerosis (SSc), Calcinosis Cutis
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
RecruitingPhase 1
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy
Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
Recruiting
Tissue Modeling in Systemic Sclerosis Using Induced Pluripotent Stem Cells (iPSCs)
Systemic Sclerosis (SSc)
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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing GC012F injection in people with Systemic Sclerosis (SSc) and Idiopathic Inflammatory Myopathy (IIM), run by Qiong Fu.
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 15 inclusion and 30 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: opening soon, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Qiong Fu (13585603288, Fuqiong5@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with dose-limiting toxicity (DLT) within 28 days after infusion. (time frame: 28 days after infusion.). The study lists 2 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 18 Jul 2025.