Systemic Lupus Erythematosus (SLE)Phase 1NCT06822881
CT1190B in the Treatment of Patients With Moderate to Severe Refractory Systemic Lupus Erythematosus (SLE) or Refractory/Progressive Systemic Sclerosis (SSc)
A Phase 1 study testing CAR-T Therapy in people with Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc), run by Beijing GoBroad Hospital at 1 site in China.
Trial summary
A Clinical Study Exploring CT1190B in the treatment of patients with moderate to severe refractory systemic lupus erythematosus (SLE) or refractory/progressive systemic sclerosis (SSc) Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc)
- 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
- 27 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2025to 31 Dec 2026
- Phase
- 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
- Voluntary signing of the Informed Consent Form (ICF)
- Age range: At the time of signing the ICF, the age is between 18 and 60 years old (including 18 and 60 years old), regardless of gender.
- No systemic active infection within 2 weeks before screening.
- Contraceptive requirements for participants with child - bearing potential.
- Negative pregnancy test for women with child - bearing potential. Inclusion Criteria for SLE
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- Meet the EULAR/ACR 2019 SLE classification criteria with a disease history ≥ 6 months.
- Treatment and disease activity requirements:
- o Before screening, the participant must have received treatment with glucocorticoids combined with immunosuppressive agents (including cyclophosphamide, mycophenolate mofetil, tacrolimus, methotrexate, cyclosporine, leflunomide) and/or biological agents for ≥ 3 months, with a stable dose for ≥ 2 weeks, and the disease is still in an active state. Oral corticosteroid requirements at the time of screening:
- o If treated with corticosteroids alone, prednisone (or equivalent drug) ≥ 7.5 mg/day.
- o When used in combination with immunosuppressive agents and/or biological agents, there is no minimum daily dose requirement for corticosteroids.
- Positive antibody test at screening: Positive antinuclear antibody, and/or positive anti-ds-DNA antibody, and/or positive anti-Smith antibody.
- Disease activity score or organ damage: At the screening stage, the SLEDAI - 2K score is ≥ 7 points
- Active organ involvement at screening: isolated skin and mucous membrane involvement is not eligible for inclusion.
- Adequate organ function:
- o Renal function: Defined as a calculated creatinine clearance rate (Cockcroft - Gault) ≥ 50 mL/min without the need for hydration assistance.
- o Bone marrow function: Defined as absolute neutrophil count (ANC) ≥ 1.0×10⁹/L and hemoglobin (Hb) ≥ 60 g/L. Blood transfusion and growth factors should not be used to meet these requirements within 7 days before the inclusion and exclusion screening.
- o Liver function: Defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2× the upper limit of normal (ULN), and total bilirubin ≤ 2× the upper limit of normal (ULN).
- o Coagulation function: Defined as international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5×ULN.
- o Lung function: Oxygen saturation (SpO₂) ≥ 92% (measured by pulse oximeter) in room air.
- Cardiac function: Defined as a left ventricular ejection fraction (LVEF) ≥ 40% as evaluated by echocardiogram (ECHO) within 8 weeks before screening.
- Meet the 2013 EULAR/ACR classification criteria for systemic sclerosis and the diffuse - type manifestation simultaneously.
- Combined with interstitial pneumonia caused by SSc.
- Meet the definition of refractory or progressive disease:
- o Refractory disease definition: Ineffective after more than 6 months of conventional treatment, or disease recurrence after remission. Conventional treatment is defined as the use of glucocorticoids (more than 1 mg/kg/d) or cyclophosphamide, and one or more of the following immunomodulatory drugs: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents including Actemra, Rituxan, belimumab, tabitacicept, etc.
- Progressive disease definition (in the past 6 months):
- Skin progression: An increase in mRSS > 10%.
- Lung disease progression: A 10% decrease in FVC, or a 5% decrease in FVC accompanied by a 15% decrease in DLCO.
- Important organ function:
- o Renal function: Defined as a calculated creatinine clearance rate (Cockcroft - Gault) ≥ 50 mL/min without the need for hydration assistance.
- o Bone marrow function: Defined as absolute neutrophil count (ANC) ≥ 1.0×10⁹/L and hemoglobin (Hb) ≥ 90 g/L. Blood transfusion and growth factors should not be used to meet these requirements within 7 days before the inclusion and exclusion screening.
- o Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2× the upper limit of normal (ULN), and total bilirubin ≤ 2× the upper limit of normal (ULN).
- o Coagulation function: INR ≤ 1.5×ULN, prothrombin time (PT) ≤ 1.5×ULN.
- o Cardiac function: Good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥ 40%.
Who cannot join
- Previous history of CAR-T cell or other genetically modified T-cell therapies, or previous major organ transplantation.
- Use of B-cell targeted drugs (such as rituximab) within 2 months before screening.
- Allergy or intolerance to lymphodepletion drugs, tocilizumab, or life-threatening allergic reactions, hypersensitivity reactions, or intolerance to the CT1190B preparation or its excipients, or a history of other severe allergies such as anaphylactic shock.
- Use of corticosteroids ≥ 10 mg/day of prednisone (or equivalent drug) within 10 days before the infusion of CT1190B.
- Use of immunosuppressive agents that affect T-cells (mycophenolate mofetil, methotrexate, cyclosporine, azathioprine, leflunomide, tacrolimus) within 10 days before the infusion of CT1190B.
- Use of JAK inhibitors (tofacitinib, baricitinib tablets, ruxolitinib, etc.) within 3 days before the infusion of CT1190B.
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- Vaccination with live-attenuated vaccines, inactivated vaccines, or RNA vaccines within 1 month before screening.
- Diagnosis of cancer within 2 years before signing the ICF. Exceptions include non-melanoma skin cancer treated by radical therapy, local prostate cancer, biopsy-proven cervical carcinoma in situ or squamous intraepithelial lesions detected by cervical smear, and completely resected breast carcinoma in situ.
- Undergoing major surgery within 4 weeks before signing the ICF, or planning to undergo major surgery during the study, and the investigator deems it will pose an unacceptable risk to the participant.
- Positive test for HIV, syphilis, active hepatitis B virus infection, or active hepatitis C virus infection at screening.
- History of central nervous system diseases before screening, including but not limited to cerebrovascular accident, encephalitis, epilepsy, convulsions/seizures, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar diseases, central nervous system vasculitis, cognitive impairment, organic brain syndrome, or mental illness.
- History of any of the following cardiovascular diseases within 1 month before screening: Heart failure of class III or IV as defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other heart diseases of significant clinical significance.
- Participation in other clinical studies within 3 months before screening or still within five half-lives after the last dose of the drug.
- Current presence of any uncontrolled active infection, including but not limited to active tuberculosis, etc.
- History or evidence of suicidal thoughts within 6 months before signing the ICF, or any suicidal behavior within the previous 12 months, and the investigator deems there is a significant suicide risk.
- Pregnant or breastfeeding women.
- Poor compliance judged by the investigator, inability or unwillingness to comply with the requirements of the study protocol, or other reasons that make the participant unsuitable for this clinical study.
- Severe lupus nephritis within 2 months before screening, requiring hemodialysis, or receiving prednisone ≥ 100 mg/d or equivalent corticosteroid treatment for ≥ 14 days.
- Lupus crisis within 1 month before screening, and the investigator deems it inappropriate for the participant to participate in this study.
- Central nervous system manifestations caused by lupus before screening, including but not limited to lupus headache, seizures, cognitive impairment, impaired intellectual function, visual impairment, etc.
- History of ≥ grade 2 bleeding within 30 days before screening.
- Plasmapheresis, plasma separation, or hemodialysis within 14 days before screening.
- 1. FVC ≤ 30% of the predicted value or DLCO (corrected for hemoglobin) ≤ 30% of the predicted value.
- 2. Combined with severe kidney disease or signs of renal crisis in the participant.
- 3. Risk of active tuberculosis at screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing GoBroad Hospital
Beijing, Beijing Municipality, 102200
Jing Pan, 010-50847588, panj@gobroaddhealthcare.com
About this study
Official title: A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1190B CAR-T Cell Therapy, in Patients With Moderate to Severe Refractory Systemic Lupus Erythematosus (SLE) or Refractory/Progressive Systemic Sclerosis (SSc)
A Clinical Study Exploring CT1190B in the treatment of patients with moderate to severe refractory systemic lupus erythematosus (SLE) or refractory/progressive systemic sclerosis (SSc)
Read the detailed description
A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1190B CAR-T Cell Therapy in Patients With moderate to severe refractory systemic lupus erythematosus (SLE) or refractory/progressive systemic sclerosis (SSc)
- Being tested
- CAR-T Therapy
- Keywords
- CT1190B
- Medical subject headings
- Lupus Erythematosus, Systemic, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T TherapyDrug
CT1190B cells infusion
| Study group | Role | What they receive |
|---|---|---|
| CT1190B CAR-T cells Injection | Experimental | CT1190B cells infusion Receives: Drug: CAR-T Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate and severity of dose limiting toxicity (DLT), adverse events (AE), serious adverse events (SAE), and AESI (adverse events of particular concern)
Measured: Within 28 days after infusion for DLT, within 180 days after infusion for AE/SAE, within 12 months after infusion for AESI
Secondary outcomes (2)
Proportion of patients who reach lupus low disease activity status (LLDAS) 6 months after infusion
Measured: Six months
Changes in American College of Rheumatology Composite Response Index in Systemic Sclerosis (ACR-CRISS) compared to baseline after 3 months of infusion
Measured: 3 months after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start20 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing GoBroad Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CARsgen Therapeutics Co., Ltd.
- Responsible party
- Principal investigator, Jing Pan, Beijing GoBroad Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822881
- Sponsor's protocol ID
- CT1190B-CG11002_03
- Status last verified
- Mar 2026
- First submitted
- 7 Feb 2025
- Last updated
- 10 Mar 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 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1190B CAR-T Cell Therapy, in Patients With Moderate to Severe Refractory Systemic Lupus Erythematosus (SLE) or Refractory/Progressive Systemic Sclerosis (SSc)
- ClinicalTrials.gov ID
- NCT06822881
- Acronym / sponsor ID
- CT1190B-CG11002_03
- Keywords
- CT1190B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Beijing GoBroad HospitalUniversity, hospital or other
- Collaborators
- CARsgen Therapeutics Co., Ltd.
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Feb 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.
A Clinical Study Exploring CT1190B in the treatment of patients with moderate to severe refractory systemic lupus erythematosus (SLE) or refractory/progressive systemic sclerosis (SSc)
Detailed description
A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1190B CAR-T Cell Therapy in Patients With moderate to severe refractory systemic lupus erythematosus (SLE) or refractory/progressive systemic sclerosis (SSc)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT1190B CAR-T cells Injection | Experimental | Drug: CAR-T TherapyCT1190B cells infusion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (34 listed)
- Voluntary signing of the Informed Consent Form (ICF)
- Age range: At the time of signing the ICF, the age is between 18 and 60 years old (including 18 and 60 years old), regardless of gender.
- No systemic active infection within 2 weeks before screening.
- Contraceptive requirements for participants with child - bearing potential.
- Negative pregnancy test for women with child - bearing potential. Inclusion Criteria for SLE
Key exclusion criteria (25 listed)
- Previous history of CAR-T cell or other genetically modified T-cell therapies, or previous major organ transplantation.
- Use of B-cell targeted drugs (such as rituximab) within 2 months before screening.
- Allergy or intolerance to lymphodepletion drugs, tocilizumab, or life-threatening allergic reactions, hypersensitivity reactions, or intolerance to the CT1190B preparation or its excipients, or a history of other severe allergies such as anaphylactic shock.
- Use of corticosteroids ≥ 10 mg/day of prednisone (or equivalent drug) within 10 days before the infusion of CT1190B.
- Use of immunosuppressive agents that affect T-cells (mycophenolate mofetil, methotrexate, cyclosporine, azathioprine, leflunomide, tacrolimus) within 10 days before the infusion of CT1190B.
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 TherapyCT1190B cells infusion | Drug | CT1190B CAR-T cells Injection |
Primary outcome
The incidence rate and severity of dose limiting toxicity (DLT), adverse events (AE), serious adverse events (SAE), and AESI (adverse events of particular concern)
Time frame: Within 28 days after infusion for DLT, within 180 days after infusion for AE/SAE, within 12 months after infusion for AESI
2 secondary outcomes
Proportion of patients who reach lupus low disease activity status (LLDAS) 6 months after infusion
Time frame: Six months
Changes in American College of Rheumatology Composite Response Index in Systemic Sclerosis (ACR-CRISS) compared to baseline after 3 months of infusion
Time frame: 3 months after 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 10 Mar 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 Phase 1 study testing CAR-T Therapy in people with Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc), run by Beijing GoBroad Hospital 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 34 inclusion and 25 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 10 Mar 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Jing Pan (010-50847588, panj@gobroaddhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rate and severity of dose limiting toxicity (DLT), adverse events (AE), serious adverse events (SAE), and AESI (adverse events of particular concern) (time frame: Within 28 days after infusion for DLT, within 180 days after infusion for AE/SAE, within 12 months after infusion for AESI). 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 10 Mar 2026.