Systemic Lupus Erythematosus (SLE)Early Phase 1NCT06420154
The Safety and Efficacy of Anti-CD19 CAR-T Cells in Patients With Relapsed/Refractory Autoimmune Diseases
A Early Phase 1 study testing anti-CD19-CAR-T cells in people with Systemic Lupus Erythematosus (SLE) and Sjogren's Syndrome, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
This is an investigator-initiated trial to evaluate the safety and efficacy of anti- CD19-CAR-T cells in the relapse or refractory autoimmune diseases. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome, Systemic Sclerosis
- What is being tested?
- anti-CD19-CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2024to 27 May 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Meet the 2022 ACR/EULAR diagnostic criteria for ANCA vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis; 2.Positive ANCA-related antibodies (MPO-ANCA or PR3-ANCA positive); 3.Birmingham Vasculitis Activity Score (BVAS) ≥15 points (total score 63 points), indicating active vasculitis; 4.There must be at least one major item, at least 3 minor items, or at least two renal items in the BVAS assessment: hematuria and proteinuria; 5.Definition of relapse and refractory: Conventional treatment is ineffective or disease activity reappears after remission. The definition of routine treatment: the use of glucocorticoids (more than 1 mg/Kg/d) and cyclophosphamide, and any one or more of the following immunomodulatory drugs for more than 6 months: antimalarial drugs, azathioprine, mycophenolate mofetil , methotrexate, leflunomide, tacrolimus, cyclosporine and biological agents including rituximab, belimumab, tatacept, etc.;
- Meet the diagnostic criteria for primary antiphospholipid syndrome revised in Sydney in 2006;
- Positive medium-to-high titer phospholipid antibodies (LA, B2GP1 or acL IgG/IgM, more than two positive tests within 12 weeks);
- Definition of relapse and refractory: use of warfarin anticoagulation or standard treatment instead of vitamin K antagonists (i.e., maintenance of the INR required for treatment) or use of standard therapeutic doses of low molecular weight heparin (LMWH), as well as use of hormones and cyclophosphamide treatment Recurrence of thrombosis;
- Catastrophic antiphospholipid syndrome requires the following four criteria:
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- Involving three or more organs, systems and/or tissues;
- Symptoms appear within 1 week;
- Histology confirms small blood vessel obstruction in at least one organ or tissue;
- aPL positive.
Who cannot join
- Combined with neuropsychiatric lupus;
- Thrombotic thrombocytopenic purpura (TTP)/microthrombotic vasculopathy (TMA).
- Relapsed and Refractory Sjogren's Syndrome Inclusion criteria：
- Meet the 2002 AECG criteria or the 2016 ACR/EULAR classification criteria for primary sjogren's syndrome;
- Definition of relapse and refractory: Conventional treatment is ineffective or disease activity reappears after remission. The definition of routine treatment: the use of glucocorticoids (more than 1 mg/Kg/d) and cyclophosphamide, and any one or more of the following immunomodulatory drugs for more than 6 months: antimalarial drugs, azathioprine, mycophenolate mofetil , methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents including rituximab, belimumab, tatacept, etc.
- Combined with liver cirrhosis;
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- Combined with aplastic anemia (AA), myelodysplastic syndrome (MDS) or other myeloproliferative diseases (MPD);
- Drug-induced thrombocytopenia;
- Thrombotic thrombocytopenic purpura (TTP)/microthrombotic vasculopathy (TMA).
- Relapsed, Refractory/Progressive Diffuse Scleroderma
- Inclusion criteria： 1.Comply with the 2013 ACR classification criteria for scleroderma and comply with diffuse manifestations; 2.Combined with interstitial pneumonia: chest HRCT shows interstitial changes with ground glass exudation and the predicted value of FVC or DLCO in pulmonary function testing is <70%; 3.Definition of relapse and refractory: Conventional treatment is ineffective or disease activity reappears after remission. The definition of routine treatment: the use of glucocorticoids (more than 1 mg/Kg/d) and cyclophosphamide, and any one or more of the following immunomodulatory drugs for more than 6 months: antimalarial drugs, azathioprine, mycophenolate mofetil , methotrexate, leflunomide, tacrolimus, cyclosporine and biological agents including rituximab, belimumab, tatacept, etc.; 4.Definition of progress:
- Definition of skin progression: mRSS increase >10%;
- Definition of lung disease progression: FVC decreases by 10%, or FVC decreases by 5% and DLCO decreases by 15% (OMERACT progression).
- New York heart function class IV;
- There is moderate to severe pulmonary hypertension (mean pulmonary artery pressure on echocardiography >40 mmHg);
- FVC <45% predicted value;
- DLCO <40% predicted value;
- Significant abnormalities on HRCT are not caused by SSc;
- Persistent unexplained hematuria (5 red blood cells under high power) or creatinine clearance <40ml/min;
- Patients who have had autologous stem cell transplantation in the past;
- There are signs of renal crisis;
- Active antral vasodilation.
- Relapsed Refractory/Progressive Inflammatory Myopathy
- Inclusion criteria： 1.Comply with the 2017 EULAR/ACR classification criteria for inflammatory myopathies (including DM, PM, ASS and NM); 2.For those with muscle involvement, the MMT-8 score is lower than 142 and there are at least two abnormal findings in the following five core measurements (PhGA, PtGA or extramuscular disease activity score ≥ 2 points; HAQ total score ≥ 0.25; muscle enzymes level is 1.5 times the upper limit of the normal range); 3.Myositis antibody positive; 4.Definition of relapse and refractory: Conventional treatment is ineffective or disease activity reappears after remission. The definition of routine treatment: the use of glucocorticoids (more than 1 mg/Kg/d) and cyclophosphamide, and any one or more of the following immunomodulatory drugs for more than 6 months: antimalarial drugs, azathioprine, mycophenolate mofetil , methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents including rituximab, belimumab, tatacept, etc.
- 5.Definition of progressive: Rapidly progressive interstitial pneumonia occurring in a short period of time.
- Drug-induced myositis
- Inclusion body myositis;
- Tumor-related myositis (myositis occurring within 2 years after tumor diagnosis).
- Relapsed and Refractory ANCA-Associated Vasculitis
- 1.Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2; 2.If the patient has alveolar hemorrhage, invasive pulmonary ventilation is required and the duration is expected to exceed the screening time; 3.Dialysis or plasma exchange is required during the screening period; 4.Have received a kidney transplant.
- Relapsed/Refractory/Catastrophic Antiphospholipid Syndrome
- Obstetric APS;
- APS merged with other CTDs;
- APS involves the nervous system.
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
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Jianxin Tu, Master's, +86 18267726068, Lstujianxin@163.com
Li Sun, Master's
About this study
Official title: An Exploratory Clinical Study to Evaluating the Safety and Efficacy of Infusiing Anti-CD19-CAR-T Cells Injection (Anti-CD19-CAR-T Cells) in Patients With Relapsed/Refractory Autoimmune Diseases
This is an investigator-initiated trial to evaluate the safety and efficacy of anti- CD19-CAR-T cells in the relapse or refractory autoimmune diseases.
Read the detailed description
This is an investigator-initiated trial to evaluate the safety and efficacy of anti- CD19-CAR-T cells in the relapse or refractory autoimmune diseases.
Study intervention consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.
Interim analysis will be performed when the last participant finishes the visit of 12 weeks after CAR-T cells infusion.
- Conditions
- Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome, Systemic Sclerosis, Inflammatory Myopathy, ANCA Associated Vasculitis, Antiphospholipid Syndrome
- Being tested
- anti-CD19-CAR-T cells
- Keywords
- CAR T, CD19, Autoimmune Diseases
- Medical subject headings
- Lupus Erythematosus, Systemic, Sjogren's Syndrome, Scleroderma, Systemic, Myositis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Antiphospholipid Syndrome, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-CD19-CAR-T cellsBiological
The subjects received infusions of anti-CD19 CAR-T cells following completion of lymphodepleting preconditioning chemotherapy.
Dosage：1×10^5 cells/Kg; 3×10^5 cells/Kg; 1×10^6 cells/Kg
frequency：single infusion
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Biological: anti-CD19-CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity
Percentage of patients receiving CAR-T cells who experience dose-limiting toxicities (DLTs).
Measured: Up to 28 days from CAR-T infusion
Laboratory abnormalities and type, frequency and severity of adverse events
Safety assessments are conducted using the NCI-CTCAE version 5.0 standards (CRS and neurotoxicity will be graded according to ASTCT/ ASBMT grading criteria)
Measured: Up to1 year from CAR-T infusion
Proportion of patients for whom a CAR-T cell product could be prepared
Percentage of subjects for whom the desired dose of anti-CD19 -CAR-T cells can be successfully manufactured
Measured: Up to 4 days from apheresis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start27 May 2024 (estimated)
- Primary completion27 May 2027 (estimated)
- Study completion27 May 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 First Affiliated Hospital of Wenzhou Medical UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai First Song Therapeutics Co., Ltd
- Responsible party
- Principal investigator, Li Sun, First Affiliated Hospital of Wenzhou Medical University
- Investigators
- LI Sun, Master's, Principal investigator, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420154
- Sponsor's protocol ID
- CD19-CN-A4
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to concerns regarding the security of patient personal information.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study to Evaluating the Safety and Efficacy of Infusiing Anti-CD19-CAR-T Cells Injection (Anti-CD19-CAR-T Cells) in Patients With Relapsed/Refractory Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT06420154
- Acronym / sponsor ID
- CD19-CN-A4
- Conditions
- Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome, Systemic Sclerosis, Inflammatory Myopathy, ANCA Associated Vasculitis, Antiphospholipid Syndrome
- Keywords
- CAR T, CD19, Autoimmune Diseases
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Shanghai First Song Therapeutics Co., Ltd
- Study start
- 27 May 2024 (estimated)
- Primary completion
- 27 May 2027 (estimated)
- Study completion
- 27 May 2027 (estimated)
- First posted
- 17 May 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.
This is an investigator-initiated trial to evaluate the safety and efficacy of anti- CD19-CAR-T cells in the relapse or refractory autoimmune diseases.
Detailed description
This is an investigator-initiated trial to evaluate the safety and efficacy of anti- CD19-CAR-T cells in the relapse or refractory autoimmune diseases.
Study intervention consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.
Interim analysis will be performed when the last participant finishes the visit of 12 weeks after CAR-T cells infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Biological: anti-CD19-CAR-T cells |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1.Meet the 2022 ACR/EULAR diagnostic criteria for ANCA vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis; 2.Positive ANCA-related antibodies (MPO-ANCA or PR3-ANCA positive); 3.Birmingham Vasculitis Activity Score (BVAS) ≥15 points (total score 63 points), indicating active vasculitis; 4.There must be at least one major item, at least 3 minor items, or at least two renal items in the BVAS assessment: hematuria and proteinuria; 5.Definition of relapse and refractory: Conventional treatment is ineffective or disease activity reappears after remission. The definition of routine treatment: the use of glucocorticoids (more than 1 mg/Kg/d) and cyclophosphamide, and any one or more of the following immunomodulatory drugs for more than 6 months: antimalarial drugs, azathioprine, mycophenolate mofetil , methotrexate, leflunomide, tacrolimus, cyclosporine and biological agents including rituximab, belimumab, tatacept, etc.;
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Key exclusion criteria (34 listed)
- Combined with neuropsychiatric lupus;
- Thrombotic thrombocytopenic purpura (TTP)/microthrombotic vasculopathy (TMA).
- Relapsed and Refractory Sjogren's Syndrome Inclusion criteria：
- Meet the 2002 AECG criteria or the 2016 ACR/EULAR classification criteria for primary sjogren's syndrome;
- Definition of relapse and refractory: Conventional treatment is ineffective or disease activity reappears after remission. The definition of routine treatment: the use of glucocorticoids (more than 1 mg/Kg/d) and cyclophosphamide, and any one or more of the following immunomodulatory drugs for more than 6 months: antimalarial drugs, azathioprine, mycophenolate mofetil , methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents including rituximab, belimumab, tatacept, 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 |
|---|---|---|
| anti-CD19-CAR-T cellsThe subjects received infusions of anti-CD19 CAR-T cells following completion of lymphodepleting preconditioning chemotherapy. Dosage：1×10^5 cells/Kg; 3×10^5 cells/Kg; 1×10^6 cells/Kg frequency：single infusion | Biological | Treatment group |
Primary outcome
Incidence of dose-limiting toxicity
Time frame: Up to 28 days from CAR-T infusion
Percentage of patients receiving CAR-T cells who experience dose-limiting toxicities (DLTs).
Laboratory abnormalities and type, frequency and severity of adverse events
Time frame: Up to1 year from CAR-T infusion
Safety assessments are conducted using the NCI-CTCAE version 5.0 standards (CRS and neurotoxicity will be graded according to ASTCT/ ASBMT grading criteria)
Proportion of patients for whom a CAR-T cell product could be prepared
Time frame: Up to 4 days from apheresis
Percentage of subjects for whom the desired dose of anti-CD19 -CAR-T cells can be successfully manufactured
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 17 May 2024.
- Individual participant dataSharing planned: No. Due to concerns regarding the security of patient personal information.
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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.
LI Sun, Master's principal investigator
First Affiliated Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing anti-CD19-CAR-T cells in people with Systemic Lupus Erythematosus (SLE) and Sjogren's Syndrome, run by First Affiliated Hospital of Wenzhou Medical University 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 10 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 May 2024. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianxin Tu, Master's (+86 18267726068, Lstujianxin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicity (time frame: Up to 28 days from CAR-T infusion). The study lists 3 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 17 May 2024.