Systemic Lupus ErythematosusPhase 1NCT07331467
Study of Ultra-Fast CD19 CAR-T Therapy for Refractory SLE
A Phase 1 study testing CD19 CAR-T cells in people with Systemic Lupus Erythematosus, run by Chongqing Precision Biotech Co., Ltd at 1 site in China.
Trial summary
This is an investigator-initiated trial aimed at assessing the safety and efficacy of ultra-fast autologous CD19-targeted CAR-T cells in the treatment of refractory systemic lupus erythematosus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- CD19 CAR-T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- Jan 2026to Aug 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old;
- Diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria, and still in moderate to severe disease activity despite ≥3M of high dose glucocorticoids(prednisone≥1mg/kg/d or other equivalent amount of other steriod), and/or hydroxychloroquine, and at least 2 DMARDs(include cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, cyclosporin, tacrolimus, sirolimus, leflunomide, telitacicept, beliumab, and rituximab) or intolerant to standard treatments;
- SLEDAI-2K score ≥ 8 points;
- Meet the standards of leukapheresis or intravenous blood collection, and no contraindication for leukapheresis;
- Negative pregnancy test for female subjects of childbearing age, and agree to take effective contraceptive measures until one year after CAR-T infusion;
- Participant or his/her guardians agree to participate in the clinical trial and sign the informed consent form which indicating that he/she understands the purpose and procedure of the clinical trial and is willing to participate in the study.
Who cannot join
- Central nervous system (CNS) disease: CNS neurolupus requires intervention within 30 days;
- Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); or NYHA classification class IV; or combined with moderate to massive pericardial effusion, serious myocarditis, etc; or patient with unstable vital signs who need hypertensive drugs;
- The functions of important organs meet one of the following conditions: (1)renal function: eGFR<30mL/min/1.73m2 or require renal replacement therapy; (2)liver function: AST and ALT>3.0 ULN, total Bilirubin (TBIL) in serum >2.0×ULN; (3)lung function: SpO2<92% with no oxygen inhalation;
- Uncontrollable infection or active infection that requires systemic treatment within 3 months prior to screening;
- Received hematopoietic stem cell transplantation within 3 months prior to screening, or ≥Grade 2 GVHD within 2 weeks prior to screening;
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; or positive for human immunodeficiency virus (HIV) antibodies; or syphilis test positive;
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- Suffered from active pulmonary tuberculosis at screening;
- Received live vaccine within 4 weeks prior to screening;
- Positive in blood pregnancy test;
- Suffered from malignant disease such as tumors (excluding tumors without active lesions and ending treatment for more than 5 years, as well as fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, thyroid cancer after radical resection, ductal carcinoma in situ after radical resection);
- Patients who participated in other clinical study within 3 months prior to screening;
- Any other conditions that the investigators deem it unsuitable for the study.
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
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu
Lingyun Sun, 13705186409, lingyunsun2012@163.com
About this study
Official title: Study of Ultra-Fast Autologous CD19-Targeted Chimeric Antigen Receptor T (CAR- T) Therapy for Refractory Systemic Lupus Erythematosus
This is an investigator-initiated trial aimed at assessing the safety and efficacy of ultra-fast autologous CD19-targeted CAR-T cells in the treatment of refractory systemic lupus erythematosus.
Read the detailed description
Systemic lupus erythematosus (SLE) is a serious autoimmune disease that can lead to extensive damage in multiple organs and systems, ultimately resulting in disability and even death.
Currently, the primary treatment for SLE relies on glucocorticoids and immunosuppressants to alleviate symptoms. However, due to the absence of a curative treatment, patients typically need to remain on medication indefinitely. In recent years, biological agents such as belimumab and rituximab have been introduced for the treatment of SLE, but these treatments cannot completely eliminate autoimmune B cells in the bone marrow, leading to unsatisfactory overall outcomes. Furthermore, discontinuing these drugs can lead to disease relapse, and there is still no cure for SLE, leaving patients facing the challenges of lifelong medication and an incurable disease.
CAR-T therapy is an adoptive cell therapy that uses genetic modification technology to reprogram T cells and eliminate target cells expressing disease-related antigens through antigen-specific recognition. Since 2019, CAR-T cell therapy has been successfully applied to autoimmune diseases. Clinical studies have demonstrated that CD19-targeted CAR-T cells hold significant therapeutic potential for SLE. Compared with traditional CAR-T cells, ultra-fast CAR-T, relying on an innovative CAR-T manufacturing system, can produce CAR-T cells in an extremely short period of time (with a preparation time of only 10 minutes).
The purpose of this study is to assess the safety and efficacy of the ultra-fast autologous CD19-targeted CAR-T cells in the treatment of refractory SLE.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- CD19 CAR-T cells
- Keywords
- CD19, CAR-T
- 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.
CD19 CAR-T cellsBiological
Three dose groups (1.5×10^5/kg, 5×10^5/kg, 10×10^5/kg) were set up, starting from the low dose group climbing to explore the safe and effective dose.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T treatment group | Experimental | This trial was designed as an open, single-arm, single-center, dose-increasing trial. Receives: Biological: CD19 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of CAR-T cell therapy in patients with refractory SLE [Safety]
Types, frequency and severity of adverse events.
Measured: 3 months
The changes from baseline in SLEDAI-2K [efficacy]
Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K) is from 0 to 105 points. The higher score means the stronger disease activity.
Measured: 6 months
The changes from baseline in PGA [efficacy]
Physician Global Assessment(PGA) is a continuous visual analogue scale with 0, 1, 2, and 3 scales. "0" indicates no disease activity and "3" indicates the most severe disease activity.
Measured: 6 months
The changes from baseline in BILAG-2004 [efficacy]
British Isles Lupus Assessment Group Index 2004(BILAG-2004) consists of 8 systems, each of which is classified as A, B, C and D respectively. "A" indicates that the condition is highly active and requires active treatment. "B" indicates that the condition is active and requires close monitoring or symptomatic treatment. "C" indicates a stable condition. "D" indicates that the system is not involved.
Measured: 6 months
The number of patients with SRI-4 response [efficacy]
The definition of SRI-4 response: SLEDAI-2K ≥ 4-Point improvement; PGA with no worsening (<0.3 point increase); BILAG 2004 with no new A domain score and no more than 1 new B domain scores.
Measured: 3 months
The number of patients with LLDAS [efficacy]
The definition of LLDAS: SLEDAI-2K ≤ 4 and no disease activity in major organs (kidneys, central nervous system, heart and lungs), and no vasculitis or fever; no new disease activity symptoms were added compared with previous disease assessments; PGA ≤ 1; irrespective of serology; with permitted use of low-dose glucocorticoids (prednisolone ≤ 7.5 mg/day), and/or stable immunosuppressives and biologics.
Measured: 6 months
The number of patients with DORIS [efficacy]
The definition of DORIS: SLEDAI-2K = 0 ; PGA < 0.5 ; irrespective of serology; with permitted use of antimalarials, low-dose glucocorticoids (prednisolone ≤ 5 mg/day), and/or stable immunosuppressives and biologics.
Measured: 6 months
Secondary outcomes (10)
The changes of anti-ds-DNA antibody after infusion [efficacy]
Measured: 6 months
The changes of 24h urine protein after infusion [efficacy]
Measured: 6 months
The changes of serum complement C3 and C4 after infusion [efficacy]
Measured: 6 months
Cmax of CAR-T cells [PK parameter]
The peak plasma concentration (Cmax) of amplified CAR-T cells in peripheral blood after infusion.
Measured: 3 months
Tmax of CAR-T cells [PK parameter]
The time of amplified CAR-T cells in peripheral blood to reach the maximum concentration (Tmax).
Measured: 3 months
AUC28d/90d of CAR-T cells [PK parameter]
The area under the plasma concentration-time curve from 28 to 90 days after infusion (AUC28d/90d).
Measured: 3 months
The degree of B cell depletion [PD parameter]
The degree of B cell depletion at various time points.
Measured: 3 months
The concentration levels of IL-6 [PD parameter]
CAR-T-related serum cytokines such as IL-6.
Measured: 3 months
The concentration levels of CRP [PD parameter]
Measured: 3 months
The concentration levels of ferritin [PD parameter]
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Chongqing Precision Biotech Co., LtdThe 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
- Model description
- Treatment of patients with refractory systemic lupus erythematosus using ultra-fast CD19-targeted CAR-T cells
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Precision Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331467
- Sponsor's protocol ID
- PBC092
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Ultra-Fast Autologous CD19-Targeted Chimeric Antigen Receptor T (CAR- T) Therapy for Refractory Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07331467
- Acronym / sponsor ID
- PBC092
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- CD19, CAR-T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Chongqing Precision Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 12 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 is an investigator-initiated trial aimed at assessing the safety and efficacy of ultra-fast autologous CD19-targeted CAR-T cells in the treatment of refractory systemic lupus erythematosus.
Detailed description
Systemic lupus erythematosus (SLE) is a serious autoimmune disease that can lead to extensive damage in multiple organs and systems, ultimately resulting in disability and even death.
Currently, the primary treatment for SLE relies on glucocorticoids and immunosuppressants to alleviate symptoms. However, due to the absence of a curative treatment, patients typically need to remain on medication indefinitely. In recent years, biological agents such as belimumab and rituximab have been introduced for the treatment of SLE, but these treatments cannot completely eliminate autoimmune B cells in the bone marrow, leading to unsatisfactory overall outcomes. Furthermore, discontinuing these drugs can lead to disease relapse, and there is still no cure for SLE, leaving patients facing the challenges of lifelong medication and an incurable disease.
CAR-T therapy is an adoptive cell therapy that uses genetic modification technology to reprogram T cells and eliminate target cells expressing disease-related antigens through antigen-specific recognition. Since 2019, CAR-T cell therapy has been successfully applied to autoimmune diseases. Clinical studies have demonstrated that CD19-targeted CAR-T cells hold significant therapeutic potential for SLE. Compared with traditional CAR-T cells, ultra-fast CAR-T, relying on an innovative CAR-T manufacturing system, can produce CAR-T cells in an extremely short period of time (with a preparation time of only 10 minutes).
The purpose of this study is to assess the safety and efficacy of the ultra-fast autologous CD19-targeted CAR-T cells in the treatment of refractory SLE.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Treatment of patients with refractory systemic lupus erythematosus using ultra-fast CD19-targeted CAR-T cells
| Arm | Type | Receives |
|---|---|---|
| CAR-T treatment group | Experimental | Biological: CD19 CAR-T cellsThis trial was designed as an open, single-arm, single-center, dose-increasing trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years old;
- Diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria, and still in moderate to severe disease activity despite ≥3M of high dose glucocorticoids(prednisone≥1mg/kg/d or other equivalent amount of other steriod), and/or hydroxychloroquine, and at least 2 DMARDs(include cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, cyclosporin, tacrolimus, sirolimus, leflunomide, telitacicept, beliumab, and rituximab) or intolerant to standard treatments;
- SLEDAI-2K score ≥ 8 points;
- Meet the standards of leukapheresis or intravenous blood collection, and no contraindication for leukapheresis;
- Negative pregnancy test for female subjects of childbearing age, and agree to take effective contraceptive measures until one year after CAR-T infusion;
Key exclusion criteria (12 listed)
- Central nervous system (CNS) disease: CNS neurolupus requires intervention within 30 days;
- Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); or NYHA classification class IV; or combined with moderate to massive pericardial effusion, serious myocarditis, etc; or patient with unstable vital signs who need hypertensive drugs;
- The functions of important organs meet one of the following conditions: (1)renal function: eGFR<30mL/min/1.73m2 or require renal replacement therapy; (2)liver function: AST and ALT>3.0 ULN, total Bilirubin (TBIL) in serum >2.0×ULN; (3)lung function: SpO2<92% with no oxygen inhalation;
- Uncontrollable infection or active infection that requires systemic treatment within 3 months prior to screening;
- Received hematopoietic stem cell transplantation within 3 months prior to screening, or ≥Grade 2 GVHD within 2 weeks prior to 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 |
|---|---|---|
| CD19 CAR-T cellsThree dose groups (1.5×10^5/kg, 5×10^5/kg, 10×10^5/kg) were set up, starting from the low dose group climbing to explore the safe and effective dose. | Biological | CAR-T treatment group |
Primary outcome
The safety of CAR-T cell therapy in patients with refractory SLE [Safety]
Time frame: 3 months
Types, frequency and severity of adverse events.
The changes from baseline in SLEDAI-2K [efficacy]
Time frame: 6 months
Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K) is from 0 to 105 points. The higher score means the stronger disease activity.
The changes from baseline in PGA [efficacy]
Time frame: 6 months
Physician Global Assessment(PGA) is a continuous visual analogue scale with 0, 1, 2, and 3 scales. "0" indicates no disease activity and "3" indicates the most severe disease activity.
The changes from baseline in BILAG-2004 [efficacy]
Time frame: 6 months
British Isles Lupus Assessment Group Index 2004(BILAG-2004) consists of 8 systems, each of which is classified as A, B, C and D respectively. "A" indicates that the condition is highly active and requires active treatment. "B" indicates that the condition is active and requires close monitoring or symptomatic treatment. "C" indicates a stable condition. "D" indicates that the system is not involved.
The number of patients with SRI-4 response [efficacy]
Time frame: 3 months
The definition of SRI-4 response: SLEDAI-2K ≥ 4-Point improvement; PGA with no worsening (<0.3 point increase); BILAG 2004 with no new A domain score and no more than 1 new B domain scores.
The number of patients with LLDAS [efficacy]
Time frame: 6 months
The definition of LLDAS: SLEDAI-2K ≤ 4 and no disease activity in major organs (kidneys, central nervous system, heart and lungs), and no vasculitis or fever; no new disease activity symptoms were added compared with previous disease assessments; PGA ≤ 1; irrespective of serology; with permitted use of low-dose glucocorticoids (prednisolone ≤ 7.5 mg/day), and/or stable immunosuppressives and biologics.
The number of patients with DORIS [efficacy]
Time frame: 6 months
The definition of DORIS: SLEDAI-2K = 0 ; PGA < 0.5 ; irrespective of serology; with permitted use of antimalarials, low-dose glucocorticoids (prednisolone ≤ 5 mg/day), and/or stable immunosuppressives and biologics.
10 secondary outcomes
The changes of anti-ds-DNA antibody after infusion [efficacy]
Time frame: 6 months
The changes of 24h urine protein after infusion [efficacy]
Time frame: 6 months
The changes of serum complement C3 and C4 after infusion [efficacy]
Time frame: 6 months
Cmax of CAR-T cells [PK parameter]
Time frame: 3 months
Tmax of CAR-T cells [PK parameter]
Time frame: 3 months
AUC28d/90d of CAR-T cells [PK parameter]
Time frame: 3 months
The degree of B cell depletion [PD parameter]
Time frame: 3 months
The concentration levels of IL-6 [PD parameter]
Time frame: 3 months
The concentration levels of CRP [PD parameter]
Time frame: 3 months
The concentration levels of ferritin [PD parameter]
Time frame: 3 months
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 12 Jan 2026.
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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 CD19 CAR-T cells in people with Systemic Lupus Erythematosus, run by Chongqing Precision Biotech Co., Ltd 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 6 inclusion and 12 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 12 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?
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 Lingyun Sun (13705186409, lingyunsun2012@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of CAR-T cell therapy in patients with refractory SLE [Safety] (time frame: 3 months). The study lists 7 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 12 Jan 2026.