Systemic Lupus Erythematosus (SLE)NCT06373081
Anti-CD19-CD3E-CAR-T Cells in Relapsed/Refractory Autoimmune Disease
A study testing Anti-CD19-CD3E-CAR-T cells in people with Systemic Lupus Erythematosus (SLE) and Sjogren's Syndrome, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
This is an investigator-initiated trial to evaluate the safety and efficacy of anti-CD19-CD3E-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-CD3E-CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2024to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
None listed.
Who cannot join
- Subjects with a history of severe drug allergies or allergic tendencies;
- Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections;
- Subjects with central nervous system diseases caused by autoimmune diseases or non-autoimmune diseases (including epilepsy, psychosis, organic brain syndrome, cerebral vascular accidents, encephalitis, central nervous system vasculitis);
- Subjects with insufficient cardiac function;
- Subjects with congenital immunoglobulin deficiencies;
- History of malignancy within five years;
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- Subjects with end-stage renal failure;
- Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA >ULN; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing;
- Subjects with psychiatric disorders and severe cognitive impairments;
- Subjects who have participated in other clinical trials within the past 3 months prior to enrollment;
- Subjects who have received biologics with therapeutic effects for indications within 4 weeks prior to enrollment;
- Subjects who have received immunosuppressive agents with therapeutic effects for indications within 2 weeks prior to enrollment;
- Subjects who have received >10mg/d prednisone or equivalent dose of other steroids within 2 weeks prior to enrollment;
- Pregnant women or women planning to conceive;
- Subjects whom the investigator believes have other reasons that make them unsuitable for inclusion in this study.
- Step 2. Assessment of eligibility for CAR-T Cells Infusion Inclusion Criteria
- Completion of Step 1 and successful preparation of CAR-T cell product;
- Adequate organ function, defined as: 1) Creatinine clearance rate (Cockcroft and Gault) >30 mL/min/1.73 m2, excluding acute decrease in CrCl due to the target disease; 2) ALT/AST ≤ 3×ULN (excluding liver enzyme elevation caused by inflammatory diseases); TBIL ≤ 1.5×ULN (Gilbert's syndrome allows TBIL ≤ 3×ULN).
- Systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment);
- >10mg/d prednisone or equivalent dose of other steroids within 72 hours prior to CAR-T infusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai ChangZheng hospital
Shanghai, 200003
Huji Xu, 86021-81885514, xuhuji@smmu.edu.cn
About this study
Official title: A Clinical Study on the Safety and Efficacy of Anti-CD19-CD3E-CAR-T Cells in the Treatment of Relapsed or Refractory Autoimmune Disease
This is an investigator-initiated trial to evaluate the safety and efficacy of anti-CD19-CD3E-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-CD3E-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 participants finish 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-CD3E-CAR-T cells
- Medical subject headings
- Lupus Erythematosus, Systemic, Sjogren's Syndrome, Scleroderma, Systemic, Myositis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Antiphospholipid Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-CD19-CD3E-CAR-T cellsBiological
The injection of anti-CD19-CD3E chimeric antigen receptor T (CAR-T) cells, referred to as anti-CD19-CD3E-CAR-T cells. The anti-CD19-CD3E-CAR protein is composed of a murine-derived CD19 single-chain variable fragment (scFv) FMC63, CD28 hinge and transmembrane regions, the intracellular domain of CD3E, the intracellular domain of CD28, and the intracellular domain of CD3ζ, all linked in sequence.
| Study group | Role | What they receive |
|---|---|---|
| Anti-CD19-CD3E-CAR-T Cells treatment | Experimental | Anti-CD19-CD3E-CAR-T cells, Autologous T-cells expressing a chimeric antigen receptor directed to CD19. Receives: Biological: Anti-CD19-CD3E-CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of dose-limiting toxicities (DLTs) (Safety)
Safety assessments, including the incidence of dose-limiting toxicities (DLTs) in patients receiving CAR-T cells, are conducted using the NCI-CTCAE version 5.0 standards.
Measured: Up to 28 days from CAR-T infusion
Proportion of patients for whom the desired dose of anti-CD19-CD3E-CAR-T cells can be successfully manufactured
Proportion of patients for whom the desired dose of anti-CD19-CD3E-CAR-T cells can be successfully manufactured
Measured: Up to 21 days from apheresis
Clinical response for relapsed/Refractory SLE
SLE Response Index 4 (SRI-4) response: Min/Max Value: Not specified; a decrease in score indicates improvement; higher scores indicate worse outcome.
Measured: 12 weeks post CAR-T infusion
Clinical response for Sjögren's Syndrome
Sjögren's tool for assessing response (STAR): Min/Max Value: Not specified; a decrease in score indicates improvement; higher scores indicate worse outcome.
Measured: 12 weeks post CAR-T infusion
Clinical response for relapsed/refractory/progressive systemic sclerosis
Composite Response Index in Systemic Sclerosis (CRISS): Min/Max Value: 0 to 1 (expressed as a probability); closer to 1 indicates a better response; higher scores indicate better outcome.
Measured: 12 weeks post CAR-T infusion
Clinical response for relapsed/refractory/progressive inflammatory myopathy
Total Improvement Score (TIS):Min/Max Value: Not specified; an increase in score indicates improvement; higher scores indicate better outcome.
Measured: 12 weeks post CAR-T infusion
Clinical response for relapsed/refractory anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis:
Birmingham vasculitis activity score (BVAS) score:Min/Max Value: 0 to 63; an increase in score indicates worsening condition; higher Scores Indicate: Worse Outcome.
Measured: 12 weeks post CAR-T infusion
Clinical response for relapsed/refractory/Catastrophic Antiphospholipid Syndrome
Evaluation of new thrombosis as an indicator of relapsed/refractory/catastrophic Antiphospholipid Syndrome; higher scores Indicate worse outcome (indicates progression of the syndrome).
Measured: 12 weeks post CAR-T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start20 Apr 2024 (estimated)
- Primary completion15 Apr 2025 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu huji, Shanghai Changzheng Hospital
- Investigators
- Huji Xu, Ph.D, MD, Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373081
- Sponsor's protocol ID
- CD19-CD3E-CN-A1
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Safety and Efficacy of Anti-CD19-CD3E-CAR-T Cells in the Treatment of Relapsed or Refractory Autoimmune Disease
- ClinicalTrials.gov ID
- NCT06373081
- Acronym / sponsor ID
- CD19-CD3E-CN-A1
- Conditions
- Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome, Systemic Sclerosis, Inflammatory Myopathy, ANCA Associated Vasculitis, Antiphospholipid Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 20 Apr 2024 (estimated)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 18 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.
This is an investigator-initiated trial to evaluate the safety and efficacy of anti-CD19-CD3E-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-CD3E-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 participants finish 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 |
|---|---|---|
| Anti-CD19-CD3E-CAR-T Cells treatment | Experimental | Biological: Anti-CD19-CD3E-CAR-T cellsAnti-CD19-CD3E-CAR-T cells, Autologous T-cells expressing a chimeric antigen receptor directed to CD19. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (20 listed)
- Subjects with a history of severe drug allergies or allergic tendencies;
- Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections;
- Subjects with central nervous system diseases caused by autoimmune diseases or non-autoimmune diseases (including epilepsy, psychosis, organic brain syndrome, cerebral vascular accidents, encephalitis, central nervous system vasculitis);
- Subjects with insufficient cardiac function;
- Subjects with congenital immunoglobulin deficiencies;
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-CD3E-CAR-T cellsThe injection of anti-CD19-CD3E chimeric antigen receptor T (CAR-T) cells, referred to as anti-CD19-CD3E-CAR-T cells. The anti-CD19-CD3E-CAR protein is composed of a murine-derived CD19 single-chain variable fragment (scFv) FMC63, CD28 hinge and transmembrane regions, the intracellular domain of CD3E, the intracellular domain of CD28, and the intracellular domain of CD3ζ, all linked in sequence. | Biological | Anti-CD19-CD3E-CAR-T Cells treatment |
Primary outcome
The incidence of dose-limiting toxicities (DLTs) (Safety)
Time frame: Up to 28 days from CAR-T infusion
Safety assessments, including the incidence of dose-limiting toxicities (DLTs) in patients receiving CAR-T cells, are conducted using the NCI-CTCAE version 5.0 standards.
Proportion of patients for whom the desired dose of anti-CD19-CD3E-CAR-T cells can be successfully manufactured
Time frame: Up to 21 days from apheresis
Proportion of patients for whom the desired dose of anti-CD19-CD3E-CAR-T cells can be successfully manufactured
Clinical response for relapsed/Refractory SLE
Time frame: 12 weeks post CAR-T infusion
SLE Response Index 4 (SRI-4) response: Min/Max Value: Not specified; a decrease in score indicates improvement; higher scores indicate worse outcome.
Clinical response for Sjögren's Syndrome
Time frame: 12 weeks post CAR-T infusion
Sjögren's tool for assessing response (STAR): Min/Max Value: Not specified; a decrease in score indicates improvement; higher scores indicate worse outcome.
Clinical response for relapsed/refractory/progressive systemic sclerosis
Time frame: 12 weeks post CAR-T infusion
Composite Response Index in Systemic Sclerosis (CRISS): Min/Max Value: 0 to 1 (expressed as a probability); closer to 1 indicates a better response; higher scores indicate better outcome.
Clinical response for relapsed/refractory/progressive inflammatory myopathy
Time frame: 12 weeks post CAR-T infusion
Total Improvement Score (TIS):Min/Max Value: Not specified; an increase in score indicates improvement; higher scores indicate better outcome.
Clinical response for relapsed/refractory anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis:
Time frame: 12 weeks post CAR-T infusion
Birmingham vasculitis activity score (BVAS) score:Min/Max Value: 0 to 63; an increase in score indicates worsening condition; higher Scores Indicate: Worse Outcome.
Clinical response for relapsed/refractory/Catastrophic Antiphospholipid Syndrome
Time frame: 12 weeks post CAR-T infusion
Evaluation of new thrombosis as an indicator of relapsed/refractory/catastrophic Antiphospholipid Syndrome; higher scores Indicate worse outcome (indicates progression of the syndrome).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 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. This study is not recruiting at the moment.
Huji Xu, Ph.D, MD principal investigator
Shanghai Changzheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-CD19-CD3E-CAR-T cells in people with Systemic Lupus Erythematosus (SLE) and Sjogren's Syndrome, run by Shanghai Changzheng Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 18 Apr 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huji Xu, Ph.D, MD (86021-81885514, xuhuji@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of dose-limiting toxicities (DLTs) (Safety) (time frame: Up to 28 days from CAR-T infusion). The study lists 8 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 18 Apr 2024.