Systemic Lupus Erythematosus (SLE)Phase 1NCT07031713
Safety, Efficacy and Cellular Metabolic Dynamics of ct1192 in Patients With Moderate to Severe Refractory SLE
A Phase 1 study testing CAR-T Therapy in people with Systemic Lupus Erythematosus (SLE), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
A clinical study to explore the safety, efficacy and cell metabolic kinetics of universal CD19/20 car-t cell injection in moderate to severe refractory systemic lupus erythematosus. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- 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
- 11 Jul 2025to 31 Mar 2027
- 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
- Meet the EULAR/ACR 2019 SLE classification criteria, with a medical history of ≥ 6 months;
- Voluntarily sign the Informed Consent Form (ICF); When signing the ICF, the age range is between 18 and 60 years old (including 18 and 60 years old), with no gender restrictions;
- No systemic active infections (such as infectious pneumonia or tuberculosis) within the first 2 weeks of screening;
- Women with fertility (defined as all physiologically capable women) must agree to use effective contraceptive methods from at least 28 days prior to the start of vaginal discharge until 1 year after CT1192 infusion. Egg donation is strictly prohibited within 1 year after receiving the study treatment infusion during the study period. Male partners with fertility must agree to use effective barrier contraception methods from the start of vaginal discharge until 1 year after CT1192 infusion, and should not donate semen or sperm throughout the entire study period;
- Women with fertility must have a negative serum β - human chorionic gonadotropin (β - hCG) test result within 48 hours prior to screening and gonorrhea treatment.
- Prior to screening, patients must have received a combination of glucocorticoids and immunosuppressants (including cyclophosphamide, mycophenolate mofetil, tacrolimus, methotrexate, cyclosporine, leflunomide) and/or biologics for at least 3 months, with a stable dose for at least 2 weeks and the disease still active. During screening, oral steroids must meet the following requirements:
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- If hormone therapy is used alone, prednisone (or equivalent medication) should be ≥ 7.5 mg/day; When used in combination with immunosuppressants and/or biologics, there is no minimum daily dose requirement for hormones; 7. Positive for anti nuclear antibodies, anti ds DNA antibodies, and/or anti Smith antibodies during screening; 8. During the screening period, if the SLEDAI-2K score is ≥ 7 points, or if there is significant organ dysfunction, such as severe immune thrombocytopenia or lupus nephritis (histologically diagnosed as active nephritis type III or IV with or without type V); 9. Active organ involvement during screening (including kidneys, heart and lungs, musculoskeletal system, blood system, blood vessels, etc.; skin and mucosal involvement alone cannot be included); 10. Adequate organ function:
- Renal function: defined as a creatinine clearance rate (Cockcroft Gault) calculated without hydration assistance of ≥ 50 mL/min;
- Bone marrow function: defined as neutrophil count (ANC) ≥ 1.0 × 109/L and hemoglobin (Hb) ≥ 60 g/L. Blood transfusions and growth factors must not be used to meet these requirements within 7 days prior to eligibility screening;
- Liver function: defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 x upper limit of normal (ULN), total bilirubin ≤ 2 x upper limit of normal (ULN)
- Coagulation function: defined as International Normalized Ratio (INR) or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN;
- Pulmonary function: Blood oxygen saturation (SpO2) ≥ 92% in indoor air (measured by pulse oximeter);
- Cardiac function: defined as a left ventricular ejection fraction (LVEF) of ≥ 50% evaluated by echocardiography (ECHO) within the first 8 weeks of screening.
Who cannot join
- Patients with severe lupus nephritis within the first 2 months of screening need to undergo hemodialysis or receive prednisone ≥ 100 mg/d or equivalent hormone therapy for ≥ 14 days;
- Have undergone plasma exchange, plasma separation, hemodialysis within 30 days prior to screening, or have had lupus crisis within 30 days prior to screening;
- Individuals with a history of ≥ grade 2 bleeding or requiring long-term anticoagulant therapy within the 30 days prior to screening;
- Screening for a history of any of the following cardiovascular diseases within the previous 30 days: Grade III or IV heart failure defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias, or other clinically significant heart diseases;
- Prior to screening, central nervous system manifestations caused by lupus, including but not limited to lupus headache, epileptic seizures, cognitive impairment, impaired intellectual function, visual impairment, etc;
- Individuals with central nervous system diseases prior to screening include but are not limited to: cerebrovascular accidents, encephalitis, epilepsy, seizures/convulsions, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar diseases, central nervous system vasculitis, cognitive dysfunction, organic brain syndrome, or psychiatric disorders;
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- No systemic active infections, including but not limited to active tuberculosis, within 2 weeks prior to screening;
- Previously received CAR-T cell or other genetically 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;
- Allergic or intolerant reactions to Qinglin drugs, tocilizumab, or life-threatening allergic reactions, hypersensitivity reactions, or intolerance to CT1192 preparations or their excipients (including dimethyl sulfoxide (DMSO)), or previous history of other severe allergies such as anaphylactic shock;
- Screening for drugs targeting B cells, such as rituximab, that have been used within the previous 6 months;
- Within the 12 weeks prior to screening, other biologics such as taceptil and belimumab have been used for treatment;
- Hormone use ≥ 10 mg/day of prednisone (or equivalent) within 2 weeks prior to CT1192 infusion, with the use of physiological substitutes, topical and inhaled steroids allowed;
- Received immunosuppressive agents that affect T cells (mycophenolate mofetil, methotrexate, cyclosporine, azathioprine, leflunomide, tacrolimus) within 2 weeks prior to CT1192 infusion;
- Have received JAK inhibitors (tofacitinib, baritinib tablets, lukatinib, etc.) within 2 weeks prior to CT1192 infusion;
- Have received attenuated live vaccine, inactivated vaccine or RNA vaccine within one month before screening;
- Suffering from malignant tumors within 2 years prior to signing the ICF. Except for the following situations: non melanoma skin cancer that has undergone 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;
- If a major surgery has been performed within 4 weeks prior to signing the informed consent form, or if a major surgery is planned during the study period, the researcher believes that it would pose unacceptable risks to the participants; During screening, there may be 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);
- 19. Participate in other clinical studies within the first 3 months of screening or still within the five half lives after the last medication; 20. Merge major chronic diseases that have not been controlled and researchers believe may increase the risk for participants; 21. If there is a history or evidence of suicidal thoughts within the previous 6 months, or any suicidal behavior within the previous 12 months, the researcher believes that there is a significant risk of suicide; 22. Pregnant or lactating women; According to the researcher's assessment, participants have poor compliance, are unable or unwilling to comply with the requirements of the research protocol, or are not suitable to participate in this clinical study for other reasons.
- 5.5 Pre cleaning standard Before clearing, the following assessment needs to be completed. If the participant meets the following criteria, clearing can be performed. Otherwise, clearing cannot be performed or may need to be delayed.
- Not using immunosuppressants in the week before Qinglin treatment;
- Female participants with fertility potential who undergo pregnancy studies within 24 hours prior to the clearance of gonorrhea and have negative results;
- Blood oxygen saturation ≥ 92% (under non auxiliary oxygen supply conditions);
- Inactive or uncontrollable systemic infection; The use of anti infective drugs within 7 days before clearing gonorrhea must be reviewed by a medical inspector;
- No signs of CNS disease or abnormal neurological examination results with clinical significance;
- Serious abnormalities in heart, lung, liver, kidney function, and endocrine disorders, including but not limited to: newly developed arrhythmias or heart failure that cannot be controlled by medication; Hypotension requiring the use of vasopressors; Bacterial, fungal, or viral infections with increased activity/progression determined by researchers;
- Researchers assess that participants are unable to comply with the requirements of the study protocol or are not suitable to continue the study in other situations.
- If a participant shows obvious abnormalities such as symptoms, signs, or test results during or after clearing the lymphatic system, the researcher must communicate with the cooperating medical monitor to discuss whether the participant is suitable to continue receiving CT1192 cell infusion.
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
Wuhan Union Hospita
Wuhan, Hubei, 430000
Qiubai Li, Professor 85726808 Ext. 027, qiubaili@hust.edu.cn
About this study
Official title: A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Dynamics of Universal CD19 / 20 Car-t Cell Injection in Moderate to Severe Refractory Systemic Lupus Erythematosus
A clinical study to explore the safety, efficacy and cell metabolic kinetics of universal CD19/20 car-t cell injection in moderate to severe refractory systemic lupus erythematosus.
This study is a single arm, open, exploratory dose increasing clinical study, which aims to evaluate the safety, efficacy and cell metabolic dynamics of ct1192 cells in patients with SLE.
Read the detailed description
The study was divided into dose increasing stage and dose expanding stage. dose escalation phase Three dose levels are tentatively determined for dose escalation: 3.0 × 108, 4.5 × 108 and 6.0 × 108 car-cd19/CD20+T cells. It is estimated that the target toxicity probability of the maximum tolerated dose is 30%, and about 12 participants are planned to be enrolled, and the number of enrolled patients in each dose group is subject to the actual situation. During the test, the researchers and partners will jointly negotiate whether to increase or decrease the dose, whether to increase to the set maximum dose group or produce the maximum available cell volume, and whether to increase the exploration of new dose level within the explored dose range (allowed to be conducted when the dose is increased or decreased) according to the participants' cell metabolism characteristics, safety, tolerance and preliminary effectiveness data, so as to determine the possible recommended therapeutic dose (RD).
The DLT observation period is 28 days after the first infusion. If the treatment needs to be withdrawn before 28 days after the infusion due to disease progression or other reasons, no obvious car-t cell expansion is detected or car-t treatment is invalid, and the DLT related AE events determined by the researcher may not be related to the product, the DLT observation period can be completed before. During each dose increase, if there is a safety risk that needs to be discussed, the researchers and partners can make a dose increase/stability/decrease decision according to the safety and tolerance of participants and the metabolic kinetics of ct1192 cells. In the same dose group, the first participant had no significant safety risk 14 days after the completion of cell infusion, and subsequent participants could only carry out cell infusion.
dose expansion phase One or more dose groups may be selected for dose expansion according to the results of the dose increasing stage to further explore the efficacy and safety in SLE patients. Each dose group and each queue plan to include up to 9 cases, and the specific number of patients in the group is subject to the actual number. DLT will not be observed in the dose expansion phase, and other research processes are the same as the dose increment phase. Researchers and collaborators will continue to monitor the safety data of the whole dose expansion phase and make decisions on admission and exit when necessary.
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Being tested
- CAR-T Therapy
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T TherapyBiological
CT1192 cells infusion
| Study group | Role | What they receive |
|---|---|---|
| CT1192 CAR-T cells Injection | Experimental | CT1192 cells infusion Receives: Biological: CAR-T Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of ct1192 in participants with moderate to severe refractory SLE
The incidence 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/SAEwithin 12 months after infusion for AESl
Evaluate the maximum tolerable dose (MTD) and/or dose range of ct1192
Ct1192 MTD and/or dose range
Measured: After medication to day 28
Secondary outcomes (15)
Proportion of participants with SLE responder index (sri-4)
Preliminary evaluation of the efficacy of ct1192 in the treatment of moderate to severe refractory SLE.Proportion of participants who reached SLE responder index (sri-4) at 6 months and other time points (1, 3, 9 and 12 months after medication)
Measured: 1, 3, 6, 9 and 12 months after drug use
Proportion of participants with low lupus disease activity status (lldas)
To evaluate the efficacy of ct1192 in the treatment of moderate to severe refractory SLE. The proportion of participants who reached lupus low disease activity status (lldas) at 6 months and other time points (1, 3, 9 and 12 months after medication).
Measured: 1, 3, 6, 9 and 12 months after drug use
Proportion of participants achieving disease remission (doris)
To evaluate the efficacy of ct1192 in the treatment of moderate to severe refractory SLE. The proportion of participants who achieved disease remission (doris) at 6 months and other time points (1, 3, 9 and 12 months after medication).
Measured: 1, 3, 6, 9 and 12 months after drug use
Changes of SLE disease activity index (sledai-2k) score from baseline after medication
To evaluate the efficacy of ct1192 in the treatment of moderate to severe refractory SLE. The SLE disease activity index (sledai-2k) scores at 6 months and other time points (1, 3, 9 and 12 months) after treatment were changed from baseline.
Measured: 1, 3, 6, 9 and 12 months after drug use
After treatment, the SLE disease activity index (Selena - SLEDAI) score changed from baseline
To evaluate the efficacy of ct1192 in the treatment of moderate to severe refractory SLE. The SLE disease activity index (Selena - SLEDAI) scores at 6 months and other time points (1, 3, 9 and 12 months) after treatment were changed from baseline.
Measured: 1, 3, 6, 9 and 12 months after drug use
After treatment, the index of lupus erythematosus assessment group (bilag-2004) changed from baseline
Preliminary evaluation of the effectiveness of CT1192 for moderate to severe refractory SLE. Changes in the British Islet Lupus Assessment Group Index (BILAG-2004) compared to baseline at 6 months and other time points (1, 3, 9, and 12 months) after medication.
Measured: 1, 3, 6, 9 and 12 months after drug use
The SLE activity score (sle-das) changed from baseline after treatment
Preliminary evaluation of the effectiveness of CT1192 for moderate to severe refractory SLE. Changes in SLE Disease Activity Score (SLE-DAS) compared to baseline at 6 months and other time points (1, 3, 9, and 12 months) after medication.
Measured: 1, 3, 6, 9 and 12 months after drug use
Changes in clinicians' overall judgment (PGA) score from baseline after medication
Preliminary evaluation of the effectiveness of CT1192 for moderate to severe refractory SLE. The overall assessment (PGA) score of clinical physicians changed from baseline at 6 months and other time points (1, 3, 9, and 12 months) after medication.
Measured: 1, 3, 6, 9 and 12 months after drug use
Proportion of patients without other SLE therapy after medication
Preliminary evaluation of the effectiveness of CT1192 for moderate to severe refractory SLE. The proportion of patients without other SLE therapies at 1, 3, 6, 9, and 12 months after medication.
Measured: 1, 3, 6, 9 and 12 months after drug use
Changes in immunoglobulin (IgG, IgM, IgA) levels during medication
Preliminary evaluation of the effectiveness of CT1192 for moderate to severe refractory SLE. Changes in immunoglobulin (IgG, IgM, IgA) levels at 1, 3, 6, 9, and 12 months after medication.
Measured: 1, 3, 6, 9 and 12 months after drug use
The changes of serum markers (anti DS DNA antibody, anti Smith antibody, antinuclear antibody Ana, complement C3) of SLE after treatment
Preliminary evaluation of the effectiveness of CT1192 for moderate to severe refractory SLE. Changes in serum markers of SLE disease (anti ds DNA antibody, anti Smith antibody, anti nuclear antibody ANA, complement C3) levels at 1, 3, 6, 9, and 12 months after medication.
Measured: 1, 3, 6, 9 and 12 months after drug use
The change value of post medication Health Assessment Questionnaire Disability Index (HAQ-DI) from baseline
Preliminary evaluation of the effectiveness of CT1192 for moderate to severe refractory SLE. Changes in Health Assessment Questionnaire Disability Index (HAQ-DI) from baseline at 1, 3, 6, 9, and 12 months after medication.
Measured: 1, 3, 6, 9 and 12 months after drug use
Copy number and duration of ct1192 gene in blood
Objective to evaluate the cell kinetics of ct1192 in SLE participants, and to observe the level and duration of ct1192 gene 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 ct1192 infusion
Evaluate the efficacy (PD) characteristics of CT1192 in SLE participants. Changes in the levels of B cell functional subgroups (initial B cells, memory B cells, plasma cells) after CT1192 infusion.
Measured: Within 1 year after CAR-T cell infusion
Changes in cytokine levels after CT1192 infusion
Evaluate the efficacy (PD) characteristics of CT1192 in SLE participants. Changes in cytokine levels after CT1192 infusion.
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 posted22 Jun 2025
- Study start11 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (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.
- 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
- 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
- NCT07031713
- Sponsor's protocol ID
- CT1192-CG11003_01
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 24 Nov 2025
- 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 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Dynamics of Universal CD19 / 20 Car-t Cell Injection in Moderate to Severe Refractory Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07031713
- Acronym / sponsor ID
- CT1192-CG11003_01
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Phase
- 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
- 11 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 22 Jun 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 to explore the safety, efficacy and cell metabolic kinetics of universal CD19/20 car-t cell injection in moderate to severe refractory systemic lupus erythematosus.
This study is a single arm, open, exploratory dose increasing clinical study, which aims to evaluate the safety, efficacy and cell metabolic dynamics of ct1192 cells in patients with SLE.
Detailed description
The study was divided into dose increasing stage and dose expanding stage. dose escalation phase Three dose levels are tentatively determined for dose escalation: 3.0 × 108, 4.5 × 108 and 6.0 × 108 car-cd19/CD20+T cells. It is estimated that the target toxicity probability of the maximum tolerated dose is 30%, and about 12 participants are planned to be enrolled, and the number of enrolled patients in each dose group is subject to the actual situation. During the test, the researchers and partners will jointly negotiate whether to increase or decrease the dose, whether to increase to the set maximum dose group or produce the maximum available cell volume, and whether to increase the exploration of new dose level within the explored dose range (allowed to be conducted when the dose is increased or decreased) according to the participants' cell metabolism characteristics, safety, tolerance and preliminary effectiveness data, so as to determine the possible recommended therapeutic dose (RD).
The DLT observation period is 28 days after the first infusion. If the treatment needs to be withdrawn before 28 days after the infusion due to disease progression or other reasons, no obvious car-t cell expansion is detected or car-t treatment is invalid, and the DLT related AE events determined by the researcher may not be related to the product, the DLT observation period can be completed before. During each dose increase, if there is a safety risk that needs to be discussed, the researchers and partners can make a dose increase/stability/decrease decision according to the safety and tolerance of participants and the metabolic kinetics of ct1192 cells. In the same dose group, the first participant had no significant safety risk 14 days after the completion of cell infusion, and subsequent participants could only carry out cell infusion.
dose expansion phase One or more dose groups may be selected for dose expansion according to the results of the dose increasing stage to further explore the efficacy and safety in SLE patients. Each dose group and each queue plan to include up to 9 cases, and the specific number of patients in the group is subject to the actual number. DLT will not be observed in the dose expansion phase, and other research processes are the same as the dose increment phase. Researchers and collaborators will continue to monitor the safety data of the whole dose expansion phase and make decisions on admission and exit when necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT1192 CAR-T cells Injection | Experimental | Biological: CAR-T TherapyCT1192 cells infusion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Meet the EULAR/ACR 2019 SLE classification criteria, with a medical history of ≥ 6 months;
- Voluntarily sign the Informed Consent Form (ICF); When signing the ICF, the age range is between 18 and 60 years old (including 18 and 60 years old), with no gender restrictions;
- No systemic active infections (such as infectious pneumonia or tuberculosis) within the first 2 weeks of screening;
- Women with fertility (defined as all physiologically capable women) must agree to use effective contraceptive methods from at least 28 days prior to the start of vaginal discharge until 1 year after CT1192 infusion. Egg donation is strictly prohibited within 1 year after receiving the study treatment infusion during the study period. Male partners with fertility must agree to use effective barrier contraception methods from the start of vaginal discharge until 1 year after CT1192 infusion, and should not donate semen or sperm throughout the entire study period;
- Women with fertility must have a negative serum β - human chorionic gonadotropin (β - hCG) test result within 48 hours prior to screening and gonorrhea treatment.
Key exclusion criteria (27 listed)
- Patients with severe lupus nephritis within the first 2 months of screening need to undergo hemodialysis or receive prednisone ≥ 100 mg/d or equivalent hormone therapy for ≥ 14 days;
- Have undergone plasma exchange, plasma separation, hemodialysis within 30 days prior to screening, or have had lupus crisis within 30 days prior to screening;
- Individuals with a history of ≥ grade 2 bleeding or requiring long-term anticoagulant therapy within the 30 days prior to screening;
- Screening for a history of any of the following cardiovascular diseases within the previous 30 days: Grade III or IV heart failure defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias, or other clinically significant heart diseases;
- Prior to screening, central nervous system manifestations caused by lupus, including but not limited to lupus headache, epileptic seizures, cognitive impairment, impaired intellectual function, visual impairment, etc;
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 TherapyCT1192 cells infusion | Biological | CT1192 CAR-T cells Injection |
Primary outcome
To evaluate the safety and tolerability of ct1192 in participants with moderate to severe refractory SLE
Time frame: Within 28 days after infusion for DLT, within 180 days after infusion fOr AE/SAEwithin 12 months after infusion for AESl
The incidence and severity of dose limiting toxicity (DLT), adverse events (AE), serious adverse events (SAE), and AESI (adverse events of particular concern)
Evaluate the maximum tolerable dose (MTD) and/or dose range of ct1192
Time frame: After medication to day 28
Ct1192 MTD and/or dose range
15 secondary outcomes
Proportion of participants with SLE responder index (sri-4)
Time frame: 1, 3, 6, 9 and 12 months after drug use
Proportion of participants with low lupus disease activity status (lldas)
Time frame: 1, 3, 6, 9 and 12 months after drug use
Proportion of participants achieving disease remission (doris)
Time frame: 1, 3, 6, 9 and 12 months after drug use
Changes of SLE disease activity index (sledai-2k) score from baseline after medication
Time frame: 1, 3, 6, 9 and 12 months after drug use
After treatment, the SLE disease activity index (Selena - SLEDAI) score changed from baseline
Time frame: 1, 3, 6, 9 and 12 months after drug use
After treatment, the index of lupus erythematosus assessment group (bilag-2004) changed from baseline
Time frame: 1, 3, 6, 9 and 12 months after drug use
The SLE activity score (sle-das) changed from baseline after treatment
Time frame: 1, 3, 6, 9 and 12 months after drug use
Changes in clinicians' overall judgment (PGA) score from baseline after medication
Time frame: 1, 3, 6, 9 and 12 months after drug use
Proportion of patients without other SLE therapy after medication
Time frame: 1, 3, 6, 9 and 12 months after drug use
Changes in immunoglobulin (IgG, IgM, IgA) levels during medication
Time frame: 1, 3, 6, 9 and 12 months after drug use
The changes of serum markers (anti DS DNA antibody, anti Smith antibody, antinuclear antibody Ana, complement C3) of SLE after treatment
Time frame: 1, 3, 6, 9 and 12 months after drug use
The change value of post medication Health Assessment Questionnaire Disability Index (HAQ-DI) from baseline
Time frame: 1, 3, 6, 9 and 12 months after drug use
Copy number and duration of ct1192 gene 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 ct1192 infusion
Time frame: Within 1 year after CAR-T cell infusion
Changes in cytokine levels after CT1192 infusion
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 24 Nov 2025.
- 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), 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 13 inclusion and 27 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 24 Nov 2025. 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 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?
To evaluate the safety and tolerability of ct1192 in participants with moderate to severe refractory SLE (time frame: Within 28 days after infusion for DLT, within 180 days after infusion fOr AE/SAEwithin 12 months after infusion for AESl). 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 24 Nov 2025.