Systemic Lupus ErythematosusEarly Phase 1NCT06711146
Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of Moderate to Severe Active SLE Clinical Research
A Early Phase 1 study testing Metabolically Armed CD19 CAR-T cells in people with Systemic Lupus Erythematosus, run by Zhejiang University at 1 site in China.
Trial summary
A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Moderate to Severe Active 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?
- Metabolically Armed CD19 CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2024to 5 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects or guardians must sign an informed consent form approved by the Ethics Committee in person before commencing any screening process;
- Be over 18 years of age, male or female;
- A diagnosis of SLE according to the 2012 systemic lupus international collaborating clinics(SLICC);
- The history of SLE prior to screening was at least 6 months, and the disease remained active at least 2 months after the use of a stable standard SLE regimen prior to screening:
- Conventional regimens for SLE are corticosteroids and one or more immunomodulatory drugs over 6 months;
- Oral corticosteroids must meet the following requirements:
Show all 27Show fewer
- Prednisone (or equivalent) ≥7.5 mg/ day, and ≤60 mg/ day;
- There is no minimum daily dose requirement for corticosteroids when used in combination with immunosuppressants;
- At least 8 weeks of treatment prior to screening, and the dose must be kept stable for > 2 weeks.
- SLEDAI-2000 score ≥8 during the screening period. Score ≥6 for SLEDAI-2000 clinical symptoms (except for low complement and/or anti-DS-DNA antibodies) if low complement and/or anti-DS-DNA antibody score is present;
- Women of childbearing age and all male patients must consent to use a effective contraception for at least 12 months after Meta10-19 infusion and until two consecutive PCR tests show no more CAR T cells in vivo;
- CD19 expression was positive by or flow cytometry ;
- Organ function:
- Complete blood count (CBC) test [the following criteria should be met within 24 hours prior to apheresis, and supportive treatment such as transfusion, platelet transfusion, cell growth factor (except recombinant erythropoietin) should be avoided within 7 days prior to detection]
- Lymphocyte count ≥ 0.5×10^9/L;
- Platelet count ≥ 25×10^9/L;
- Hemoglobin ≥ 70.0 g/L
- Blood Biochemistry:
- Serum creatinine (Scr) ≤ 1.5 x ULN, or
- endogenous creatinine clearance ≥ 40 mL/min (using Cockcroft-Gault formula);
- alanine aminotransferase (ALT) ≤ 2.5 x ULN;
- aspartate aminotransferase (AST) ≤ 2.5 ×ULN;
- Total bilirubin (TBIL) ≤ 2 ×ULN; Subjects with total bilirubin < 3 × ULN and direct bilirubin < 1.5× ULN with Gilbert-.Meulengracht syndrome could be included;
- Serum lipase and amylase ≤ 1.5×ULN;
- Alkaline phosphatase (ALP) ≤ 2.5 ×ULN.
- Pulmonary function: ≤CTCAE grade 1 dyspnea and oxygen saturation of blood (SaO2) > 91% in indoor air environment..
- Hemodynamic stability was determined by echocardiography or multichannel radionuclide angiography (MUGA) and LVEF ≥45%.
Who cannot join
- Prior to screening, other lupus crises, such as active central nervous system lupus, severe myocardial damage, severe lupus pneumonia or pulmonary hemorrhage, severe lupus hepatitis, and severe vasculitis.
- Clinically significant central nervous system diseases or pathological changes not caused by lupus prior to screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions/convulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
- History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
- IgA deficiency was present during screening (serum IgA level < 10 mg/dL).
- Other conditions that the investigator considered should not be enrolled in this clinical 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
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, 310000
He Huang, MD, 86-13605714822, hehuangyu@126.com
Yongxian Hu, MD, 86-15957162012, huyongxian2000@aliyun.com
About this study
A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Moderate to Severe Active Systemic Lupus Erythematosus
Read the detailed description
This is a single arm, open-label study. This study is indicated for moderate to severe active systemic lupus erythematosus. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products and our earlier disclosed clinical trials .
- Main research objectives: To evaluate the safety of metabolically armed CD19 CAR-T Cells in the treatment of moderate to severe active SLE.
- Secondary research objectives:
- To evaluate the efficacy, pharmacokinetic (PK)/pharmacodynamic (PD) characteristics, and persistence of metabolically armored CD19 CAR-T cells for moderate to severe active SLE, and their relationship with the number of B cells.
- To evaluate the effects of the concentration of autoimmune antibodies and complement after infusion of metabolically armed CD19 CAR-T Cells.
- To further explore the feasibility and safety of CAR-T therapy regimens without lymphodepletion pretreatment.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Metabolically Armed CD19 CAR-T cells
- Keywords
- Meta10-19, CAR-T Cells Therapy, Systemic Lupus Erythematosus
- 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.
Metabolically Armed CD19 CAR-T cellsDrug
Also called Meta10-19
Each subject receive metabolically armed CD19 CAR- T cells by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Administration of Metabolically Armed CD19 CAR-T cells | Experimental | Patients undergo peripheral whole blood collection. CD19 CAR-T cells infusion will be performed without prior lymphodepletion chemotherapy whenever the investigator determines that the subject can tolerate this approach. Preconditioning with fludarabine and cyclophosphamide (FC regimen) will be reserved exclusively for cases where the investigator deems lymphodepletion essential to enhance treatment response. If administered, the FC regimen will be given 5 to 7 days prior to CD19 CAR-T cells infusion. A dose of metabolically armed CD19 CAR-T cells will be infused on day 0. Receives: Drug: Metabolically Armed CD19 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
Determine the Maximal Tolerable Dose(MTD).
Measured: MTD will be determined based on Dose-limiting toxicity (DLTs) observed during the first 35 days of study treatment.
DLTs
Adverse events assessed according to NCI-CTCAE v5.0 criteria.
Measured: Up to 35 days after META 10-19 infusion.
Incidence of treatment-emergent adverse events(TEAEs)
To characterize the safety of META10-19 for moderate to severe active SLE.
Measured: Up to 12 months after META 10-19 infusion
Secondary outcomes (6)
Proportion of subjects achieving DORIS remission
DORIS remission will be assessed based on the 2021 DORIS remission criteria.
Measured: on Day 28, Month 3, and Month 6 following META 10-19 infusion.
Proportion of subjects achieving Lupus Low Disease Activity State (LLDAS)
Measured: on Day 28, Month 3, and Month 6 following META 10-19 infusion.
Proportion of subjects achieving SRI-4
SRI-4 (SLE Responder Index-4) response, assessed using SLEDAI-2000, BILAG, and PGA scores.
Measured: on Day 28, Month 3, and Month 6 following META 10-19 infusion.
Concentration of CAR-T cells
Concentration of CAR-T cells measured by Flow cytometry after CAR-T infusion.
Measured: Up to 12 months after CAR-T treatment.
Pharmacodynamics of CAR-T cells
Concentration levels of CAR-T related serum cytokines such as CRP, IL-6, IFN-γ at each time point.
Measured: Up to 28 days after infusion.
Autoantibody detection
Concentration levels of B cell related serum antibodies such as complement factor C3 , ANA, anti-dsDNA each time point.
Measured: Up to 12 months after CAR-T treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start24 Dec 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion5 Apr 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 Zhejiang 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Leman Biotech Co., Ltd.
- Responsible party
- Principal investigator, He Huang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711146
- Sponsor's protocol ID
- Meta10-19-007
- Status last verified
- Mar 2026
- First submitted
- 26 Nov 2024
- Last updated
- 24 Aug 2026
- 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 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of Moderate to Severe Active SLE Clinical Research
- ClinicalTrials.gov ID
- NCT06711146
- Acronym / sponsor ID
- Meta10-19-007
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Meta10-19, CAR-T Cells Therapy, Systemic Lupus Erythematosus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Leman Biotech Co., Ltd.
- Study start
- 24 Dec 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 5 Apr 2027 (estimated)
- First posted
- 2 Dec 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.
A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Moderate to Severe Active Systemic Lupus Erythematosus
Detailed description
This is a single arm, open-label study. This study is indicated for moderate to severe active systemic lupus erythematosus. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products and our earlier disclosed clinical trials .
- Main research objectives: To evaluate the safety of metabolically armed CD19 CAR-T Cells in the treatment of moderate to severe active SLE.
- Secondary research objectives:
- To evaluate the efficacy, pharmacokinetic (PK)/pharmacodynamic (PD) characteristics, and persistence of metabolically armored CD19 CAR-T cells for moderate to severe active SLE, and their relationship with the number of B cells.
- To evaluate the effects of the concentration of autoimmune antibodies and complement after infusion of metabolically armed CD19 CAR-T Cells.
- To further explore the feasibility and safety of CAR-T therapy regimens without lymphodepletion pretreatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Administration of Metabolically Armed CD19 CAR-T cells | Experimental | Drug: Metabolically Armed CD19 CAR-T cellsPatients undergo peripheral whole blood collection. CD19 CAR-T cells infusion will be performed without prior lymphodepletion chemotherapy whenever the investigator determines that the subject can tolerate this approach. Preconditioning with fludarabine and cyclophosphamide (FC regimen) will be reserved exclusively for cases where the investigator deems lymphodepletion essential to enhance treatment response. If administered, the FC regimen will be given 5 to 7 days prior to CD19 CAR-T cells infusion. A dose of metabolically armed CD19 CAR-T cells will be infused on day 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- All subjects or guardians must sign an informed consent form approved by the Ethics Committee in person before commencing any screening process;
- Be over 18 years of age, male or female;
- A diagnosis of SLE according to the 2012 systemic lupus international collaborating clinics(SLICC);
- The history of SLE prior to screening was at least 6 months, and the disease remained active at least 2 months after the use of a stable standard SLE regimen prior to screening:
- SLEDAI-2000 score ≥8 during the screening period. Score ≥6 for SLEDAI-2000 clinical symptoms (except for low complement and/or anti-DS-DNA antibodies) if low complement and/or anti-DS-DNA antibody score is present;
Key exclusion criteria (5 listed)
- Prior to screening, other lupus crises, such as active central nervous system lupus, severe myocardial damage, severe lupus pneumonia or pulmonary hemorrhage, severe lupus hepatitis, and severe vasculitis.
- Clinically significant central nervous system diseases or pathological changes not caused by lupus prior to screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions/convulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
- History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
- IgA deficiency was present during screening (serum IgA level < 10 mg/dL).
- Other conditions that the investigator considered should not be enrolled in this clinical study.
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 |
|---|---|---|
| Metabolically Armed CD19 CAR-T cellsAlso: Meta10-19Each subject receive metabolically armed CD19 CAR- T cells by intravenous infusion | Drug | Administration of Metabolically Armed CD19 CAR-T cells |
Primary outcome
MTD
Time frame: MTD will be determined based on Dose-limiting toxicity (DLTs) observed during the first 35 days of study treatment.
Determine the Maximal Tolerable Dose(MTD).
DLTs
Time frame: Up to 35 days after META 10-19 infusion.
Adverse events assessed according to NCI-CTCAE v5.0 criteria.
Incidence of treatment-emergent adverse events(TEAEs)
Time frame: Up to 12 months after META 10-19 infusion
To characterize the safety of META10-19 for moderate to severe active SLE.
6 secondary outcomes
Proportion of subjects achieving DORIS remission
Time frame: on Day 28, Month 3, and Month 6 following META 10-19 infusion.
Proportion of subjects achieving Lupus Low Disease Activity State (LLDAS)
Time frame: on Day 28, Month 3, and Month 6 following META 10-19 infusion.
Proportion of subjects achieving SRI-4
Time frame: on Day 28, Month 3, and Month 6 following META 10-19 infusion.
Concentration of CAR-T cells
Time frame: Up to 12 months after CAR-T treatment.
Pharmacodynamics of CAR-T cells
Time frame: Up to 28 days after infusion.
Autoantibody detection
Time frame: Up to 12 months after CAR-T treatment
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 Aug 2026.
- 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 Early Phase 1 study testing Metabolically Armed CD19 CAR-T cells in people with Systemic Lupus Erythematosus, run by Zhejiang 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 27 inclusion and 5 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 Aug 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?
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 Mingming Zhang (86-13656674208, mingmingzhang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (time frame: MTD will be determined based on Dose-limiting toxicity (DLTs) observed during the first 35 days of study treatment.). 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 24 Aug 2026.