Systemic Lupus ErythematosusPhase 1NCT06349343
CD19/BCMA CAR-T Cell Therapy for Refractory/Moderate-to-severe Systemic Lupus Erythematosus
A Phase 1 study testing CD19/BCMA CAR-T cell therapy in people with Systemic Lupus Erythematosus, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
The purpose of the study is to explore the safety and efficacy of cluster of differentiation 19 (CD19)/B cell maturation antigen (BCMA) CAR-T cell therapy in refractory/moderate-to-severe systemic lupus erythematosus(SLE). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- CD19/BCMA CAR-T cell therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2025to Jan 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants or their legal guardians understand and voluntarily sign the informed consent form, and be able to complete all the documents, procedures, follow-up examinations and treatments specified in the study protocol, with good compliance;
- Age range from 18 to 70 years old, regardless of gender;
- Participants diagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR)/the American College of Rheumatology (ACR) SLE criteria at least 24 weeks prior to screening;
- Refractory/moderate-to-severe SLE needs to meet the following criteria at screening: SELENA-SLEDAI score > 6 points; PGA ≥ 1 points; BILAG-2004 organ system scores of at least 1 A or 2 B;Have received at least 12 weeks of standardized treatment for SLE prior to screening but lack efficacy;
- Participants with fertility agree to take effective contraceptive measures throughout the study and within 3 months after the last follow-up visit.
Who cannot join
- Diagnosis of active severe lupus nephritis within 8 weeks prior to screening, requiring medications prohibited by the research protocol for active nephritis, hemodialysis or prednisone ≥ 100 mg/d, or equivalent glucocorticoid therapy for ≥14 days;
- Any attempted suicide or suicidal ideation within the past year prior to screening;
- Presence of SLE or non-SLE related central nervous system diseases or pathological changes within 8 weeks prior to screening;
- Previous or current diagnosis of non-SLE-related inflammatory arthropathy or skin diseases;
- History of vital organ transplantation or hematopoietic stem cell/or bone marrow transplantation;
- History of lymphoproliferative diseases;
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- Subjects with malignancy within 5 years prior to screening;
- Have received plasma exchange, plasma separation, hemodialysis, or intravenous immunoglobulin (IVIG) within 14 days prior to screening;
- Other autoimmune diseases requiring systemic therapy;
- Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and HBV DNA titer in peripheral blood higher than the lower limit of research institution's test range. Subjects with positive hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antibodies, or syphilis;
- Active or latent tuberculosis at screening;
- Abnormalities in major organ function at screening;
- Previous or current diagnosis of acute or chronic illnesses unrelated to SLE with obviously unstable or uncontrollable clinical symptoms;
- Severe lupus lung damage at screening;
- Severe lupus cardiac damage at screening;
- Presence of uncontrollable infections at screening, requiring antibiotic therapy;
- Have received live/attenuated vaccination within 4 weeks prior to screening or plan to receive live/attenuated vaccination throughout the study;
- Have received intra-articular, intramuscular or intravenous glucocorticoids within 4 weeks prior to screening;
- Have received any commercially available Janus kinase (JAK) inhibitor or Bruton tyrosine kinase (BTK) inhibitor within 12 weeks prior to screening;
- Have received B-cell targeted therapy prior to screening;
- Have received a biologic agent other than B-cell targeted therapy within 5 half-lives prior to screening;
- Previously received therapies with CAR-T cells or other genetically modified T cells;
- Have received therapeutic dose of corticosteroids within 7 days prior to leukapheresis or within 72 hours prior to infusion;
- Subjects that have donated blood for ≥ 400mL or had a significant blood loss equivalent to at least 400mL within 4 weeks prior to screening, or have received blood transfusion within 8 weeks, or plan to donate blood during the study period;
- History of ≥grade 2 bleeding within 4 weeks prior to screening or need for long-term continuous anticoagulant therapy;
- Subjects that have undergone any major surgeries within 12 weeks prior to screening, or those who are scheduled to undergo major surgery during the study period;
- History of drug abuse within 12 weeks prior to screening;
- Female subjects who are pregnant or lactating, or intend to conceive within 2 years after the cell infusion; male patients whose female partners intend to conceive within 2 years after the cell infusion;
- History of any significant drug allergy or intolerance;
- Subjects that have participated in other clinical trials within 3 months prior to screening and/or currently participated in other clinical trials (those who do not receive study drugs are excluded);
- Presence of other circumstances that make the subjects not eligible for participation in the study, in the opinion of the researchers.
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
Union Hospital Tongji Medical College HUAZHONG University of Science and Technology
Wuhan
Qiubai Li, PhD, qiubaili@hust.edu.cn
About this study
Official title: Clinical Study of the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Refractory/Moderate-to-severe Systemic Lupus Erythematosus
The purpose of the study is to explore the safety and efficacy of cluster of differentiation 19 (CD19)/B cell maturation antigen (BCMA) CAR-T cell therapy in refractory/moderate-to-severe systemic lupus erythematosus(SLE).
Read the detailed description
The prognosis of patients with refractory/moderate-to-severe systemic lupus erythematosus (SLE) remains poor, due to two major therapeutic obstacles: (1) current treatment strategies including glucocorticoids, immunosuppressive agents, biological agents, are still difficult to achieve disease control, making the disease condition of some patients continue to be active or even worse; (2) some patients are unable to wean themselves off glucocorticoid and face the risk of numerous adverse effects caused by long-term glucocorticoid dependence, such as glucocorticoid-related diabetes, femoral head necrosis, hypertension, stress ulcers, and infection, etc. Therefore, there is a strong unmet clinical need for more effective treatment for patients suffering from refractory/moderate-to-severe SLE. Several preclinical and clinical studies have shown the efficacy of chimeric antigen receptor T (CAR-T) cell therapy in SLE. The aim of this study is to investigate the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of cluster of differentiation 19 (CD19)/B cell maturation antigen (BCMA) CAR-T cell therapy in refractory/moderate-to-severe SLE. Patients with refractory/moderate-to-severe SLE will be invited to participate in the study, to receive CD19/BCMA CAR-T cell intravenous infusion and follow-up visits of up to 1 years after enrollment. Given that the pretreatment chemotherapy (fludarabine,cyclophosphamide) of CAR-T therapy in current SLE clinical studies is mostly based on experiences in hematologic malignancies, which may cause severe complications such as infection, there is a lack of evidence-based rationale for patients with SLE to receive pretreatment chemotherapy. This study will explore the feasibility of CAR-T cell therapy without pretreatment chemotherapy in the treatment of refractory/moderate-to-severe systemic lupus erythematosus.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- CD19/BCMA CAR-T cell therapy
- Keywords
- Refractory/Moderate-to-severe systemic lupus erythematosus, CAR-T cell therapy, CD19, BCMA
- 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/BCMA CAR-T cell therapyBiological
CD19/BCMA CAR-T cell will be infused intravenously at 3 doses: Dose A, Dose B, Dose C.
| Study group | Role | What they receive |
|---|---|---|
| CD19/BCMA CAR-T cell therapy intervention | Experimental | The first 3 participants will be enrolled to receive CAR-T cell infusion without pretreatment chemotherapy. Then participants' peripheral blood samples would be collected for CAR-T cell testing. If test results showed the presence of CAR-T cells on certain time points, CAR-T cell therapy without pretreatment chemotherapy is considered feasible, and the subsequent 17 participants will receive the consistent regimen; Otherwise, the 3 participants will be re-treated with pretreatment chemotherapy and CAR-T cell infusion, and the subsequent 17 participants will receive pretreatment chemotherapy-containing regimen. Receives: Biological: CD19/BCMA CAR-T cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Safety and tolerability will be assessed by incidence and severity of adverse events (AEs) and serious AEs (SAEs). Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) are graded by ASTCT criteria, other AEs are assessed by CTCAE V5.0 criteria
Measured: Within 1 years after CAR-T cell infusion
Secondary outcomes (6)
Proportion of subjects with SRI-4 response
SRI-4 response is defined as: 1) the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score decrease by no less than 4 points from baseline; 2) the British Isles Lupus Assessment Group (BILAG) score with no new A domain score and no more than 1 new B domain score compared to baseline; 3) the Physician Global Assessment (PGA) score increase less than 0.3 point from baseline.
Measured: Within 1 years after CAR-T cell infusion(month 1, month 3, month 6, month 9, month 12）
Changes in the Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score from baseline
Range [0, 105]，higher score represents worse disease activity
Measured: Within 1 years after CAR-T cell infusion(month 1, month 3, month 6, month 9, month 12）
Changes in the BILAG-2004 score from baseline
Range [0, 72]，higher score represents worse disease activity
Measured: Within 1 years after CAR-T cell infusion(month 1, month 3, month 6, month 9, month 12）
Changes in the Physician Global Assessment (PGA) score from baseline
Range [0, 3]，higher score represents worse disease activity
Measured: Within 1 years after CAR-T cell infusion(month 1, month 3, month 6, month 9, month 12）
Pharmacokinetics (PK)
Concentration of CAR-T cell in peripheral blood will be evaluated
Measured: Within 1 years after CAR-T cell infusion(per 3 days in month 1, per month in month 2 - month 12）
Pharmacodynamics (PD)
Pharmacodynamics (PD) will be assessed by levels of cytokines(IL-2、IL-6、IL-10、IFN-γ), changes of lymphocyte subsets, immunological indexes(IgG、IgM、IgA、IgE) in peripheral blood
Measured: Within 1 years after CAR-T cell infusion(per 3 days in month 1, per month in month 2 - month 12）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start10 Feb 2025
- Primary completionJan 2026 (estimated)
- Study completionJan 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 ErythematosusStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiubai Li, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Qiubai Li, Professor, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349343
- Sponsor's protocol ID
- UHCT230949
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2024
- Last updated
- 26 Mar 2025
- Results posted
- 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 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Refractory/Moderate-to-severe Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06349343
- Acronym / sponsor ID
- UHCT230949
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Refractory/Moderate-to-severe systemic lupus erythematosus, CAR-T cell therapy, CD19, BCMA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 5 Apr 2024 (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.
The purpose of the study is to explore the safety and efficacy of cluster of differentiation 19 (CD19)/B cell maturation antigen (BCMA) CAR-T cell therapy in refractory/moderate-to-severe systemic lupus erythematosus(SLE).
Detailed description
The prognosis of patients with refractory/moderate-to-severe systemic lupus erythematosus (SLE) remains poor, due to two major therapeutic obstacles: (1) current treatment strategies including glucocorticoids, immunosuppressive agents, biological agents, are still difficult to achieve disease control, making the disease condition of some patients continue to be active or even worse; (2) some patients are unable to wean themselves off glucocorticoid and face the risk of numerous adverse effects caused by long-term glucocorticoid dependence, such as glucocorticoid-related diabetes, femoral head necrosis, hypertension, stress ulcers, and infection, etc. Therefore, there is a strong unmet clinical need for more effective treatment for patients suffering from refractory/moderate-to-severe SLE. Several preclinical and clinical studies have shown the efficacy of chimeric antigen receptor T (CAR-T) cell therapy in SLE. The aim of this study is to investigate the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of cluster of differentiation 19 (CD19)/B cell maturation antigen (BCMA) CAR-T cell therapy in refractory/moderate-to-severe SLE. Patients with refractory/moderate-to-severe SLE will be invited to participate in the study, to receive CD19/BCMA CAR-T cell intravenous infusion and follow-up visits of up to 1 years after enrollment. Given that the pretreatment chemotherapy (fludarabine,cyclophosphamide) of CAR-T therapy in current SLE clinical studies is mostly based on experiences in hematologic malignancies, which may cause severe complications such as infection, there is a lack of evidence-based rationale for patients with SLE to receive pretreatment chemotherapy. This study will explore the feasibility of CAR-T cell therapy without pretreatment chemotherapy in the treatment of refractory/moderate-to-severe systemic lupus erythematosus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD19/BCMA CAR-T cell therapy intervention | Experimental | Biological: CD19/BCMA CAR-T cell therapyThe first 3 participants will be enrolled to receive CAR-T cell infusion without pretreatment chemotherapy. Then participants' peripheral blood samples would be collected for CAR-T cell testing. If test results showed the presence of CAR-T cells on certain time points, CAR-T cell therapy without pretreatment chemotherapy is considered feasible, and the subsequent 17 participants will receive the consistent regimen; Otherwise, the 3 participants will be re-treated with pretreatment chemotherapy and CAR-T cell infusion, and the subsequent 17 participants will receive pretreatment chemotherapy-containing regimen. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants or their legal guardians understand and voluntarily sign the informed consent form, and be able to complete all the documents, procedures, follow-up examinations and treatments specified in the study protocol, with good compliance;
- Age range from 18 to 70 years old, regardless of gender;
- Participants diagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR)/the American College of Rheumatology (ACR) SLE criteria at least 24 weeks prior to screening;
- Refractory/moderate-to-severe SLE needs to meet the following criteria at screening: SELENA-SLEDAI score > 6 points; PGA ≥ 1 points; BILAG-2004 organ system scores of at least 1 A or 2 B;Have received at least 12 weeks of standardized treatment for SLE prior to screening but lack efficacy;
- Participants with fertility agree to take effective contraceptive measures throughout the study and within 3 months after the last follow-up visit.
Key exclusion criteria (31 listed)
- Diagnosis of active severe lupus nephritis within 8 weeks prior to screening, requiring medications prohibited by the research protocol for active nephritis, hemodialysis or prednisone ≥ 100 mg/d, or equivalent glucocorticoid therapy for ≥14 days;
- Any attempted suicide or suicidal ideation within the past year prior to screening;
- Presence of SLE or non-SLE related central nervous system diseases or pathological changes within 8 weeks prior to screening;
- Previous or current diagnosis of non-SLE-related inflammatory arthropathy or skin diseases;
- History of vital organ transplantation or hematopoietic stem cell/or bone marrow transplantation;
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/BCMA CAR-T cell therapyCD19/BCMA CAR-T cell will be infused intravenously at 3 doses: Dose A, Dose B, Dose C. | Biological | CD19/BCMA CAR-T cell therapy intervention |
Primary outcome
Safety and tolerability
Time frame: Within 1 years after CAR-T cell infusion
Safety and tolerability will be assessed by incidence and severity of adverse events (AEs) and serious AEs (SAEs). Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) are graded by ASTCT criteria, other AEs are assessed by CTCAE V5.0 criteria
6 secondary outcomes
Proportion of subjects with SRI-4 response
Time frame: Within 1 years after CAR-T cell infusion(month 1, month 3, month 6, month 9, month 12）
Changes in the Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score from baseline
Time frame: Within 1 years after CAR-T cell infusion(month 1, month 3, month 6, month 9, month 12）
Changes in the BILAG-2004 score from baseline
Time frame: Within 1 years after CAR-T cell infusion(month 1, month 3, month 6, month 9, month 12）
Changes in the Physician Global Assessment (PGA) score from baseline
Time frame: Within 1 years after CAR-T cell infusion(month 1, month 3, month 6, month 9, month 12）
Pharmacokinetics (PK)
Time frame: Within 1 years after CAR-T cell infusion(per 3 days in month 1, per month in month 2 - month 12）
Pharmacodynamics (PD)
Time frame: Within 1 years after CAR-T cell infusion(per 3 days in month 1, per month in month 2 - month 12）
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 26 Mar 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.
Qiubai Li, Professor principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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/BCMA CAR-T cell therapy in people with Systemic Lupus Erythematosus, 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 5 inclusion and 31 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 26 Mar 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?
Safety and tolerability (time frame: Within 1 years after CAR-T cell infusion). 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 26 Mar 2025.