BridgeMD
Tests treatment safety and results for Systemic Lupus Erythematosus
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
What this study is testing
What is Metabolically Armed CD19 CAR-T cells?
Metabolically Armed CD19 CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for systemic lupus erythematosus.
Also referred to as Meta10-19.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Moderate to Severe Active Systemic Lupus Erythematosus
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- All people 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...
- Conventional regimens for SLE are corticosteroids and one or more immunomodulatory drugs over 6 months；
You likely can't join if
- Severe lupus nephritis (defined as proteinuria \> 6 g/24h or serum creatinine \> 2.5 mg/dL or 221 μmol/L), treatment with active nephritis with...
- Prior to screening, other lupus crises, such as active central nervous system lupus, severe hemolytic anemia, severe thrombocytopenic purpura, severe...
- Clinically significant central nervous system diseases or pathological changes not caused by lupus prior to screening, including but not limited to...
- Combined with other autoimmune diseases, systematic treatment is needed.
- 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).
See the full eligibility criteria
- All people 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:
- 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.
- Screening is positive for antinuclear antibodies, and/or anti-DS-DNA antibodies, and/or anti-Smith antibodies；
- SELENA-SLEDAI score ≥8 during the screening period. Score ≥6 for SELENA-SLEDAI 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...
- Lymphocyte count ≥ 0.5×109/L (except for those receiving bridging chemotherapy);
- Platelet count ≥ 25×109/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; people 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;
- In case of bone or liver metastasis, AST, ALT and ALP ≤ 5 ×ULN;
- Prothrombin time (PT) extended ≤ 4 s, fibrinogen ≥ 1 g/L, activated partial thromboplastin time (APTT) ≤ 1.5 ×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％.
- Severe lupus nephritis (defined as proteinuria \> 6 g/24h or serum creatinine \> 2.5 mg/dL or 221 μmol/L), treatment with active nephritis with Prohibited drugs, hemodialysis, or prednisone ≥100 within 8 weeks prior to...
- Prior to screening, other lupus crises, such as active central nervous system lupus, severe hemolytic anemia, severe thrombocytopenic purpura, severe agranulocytosis, severe myocardial damage, severe lupus pneumonia or...
- 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...
- Combined with other autoimmune diseases, systematic treatment is needed.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.