Systemic Lupus Erythematosus study: YTS109 cell
Official title A Clinical Study of YTS109 Cell for R/R Autoimmune Diseases
ClinicalTrials.gov ID: NCT07104721
What this study is testing
What is YTS109 cell?
This is an investigational cell therapy being studied as a potential treatment for Systemic Lupus Erythematosus (SLE).
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
- The study aims to see if YTS109 cells are safe and may help treat these diseases. It also looks at how the cells behave in the body.
- Who it's for
- Adults aged 18‑65 who have autoimmune conditions that have not responded to other treatments, such as lupus, lupus nephritis, systemic sclerosis, inflammatory myopathy, vasculitis, or antiphospholipid syndrome.
- What's involved
- Participants will receive one infusion of YTS109 cells. The dose will start low and may increase in a 3‑plus‑3 pattern to find the safest amount.
- Time commitment
- The study involves a single infusion and follow‑up visits to monitor safety and effectiveness. The exact length of follow‑up is not specified in the source.
- 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 to 65
You may be able to join if
- Bone marrow: Neutrophils ≥1×10\^9/L (within 2 weeks, excluding granulocyte colony-stimulating factor use); Hemoglobin ≥60 g/L.
- Liver: ALT/AST ≤3×ULN (disease-related elevations permitted). TBIL≤1.5×ULN (disease-related elevations permitted).
- Renal: CrCl≥30mL/min (Cockcroft-Gault formula, excluding acute declines).
- Coagulation: INR/PT ≤1.5×ULN.
- Meeting the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for systemic lupus...
You likely can't join if
- Individuals with a severe history of drug allergies or those with an allergic constitution;
- Individuals with existing or suspected uncontrolled or treatable fungal, bacterial, viral, or other infections;
- people with central nervous system diseases (excluding those with a history of epilepsy, psychiatric disorders, organic brain disease syndromes...
- people whose cardiac function cannot tolerate the study interventions;
- people with congenital immunoglobulin deficiencies;
- people with a history of malignant tumors within the past five years;
See the full eligibility criteria
- Bone marrow: Neutrophils ≥1×10\^9/L (within 2 weeks, excluding granulocyte colony-stimulating factor use); Hemoglobin ≥60 g/L.
- Liver: ALT/AST ≤3×ULN (disease-related elevations permitted). TBIL≤1.5×ULN (disease-related elevations permitted).
- Renal: CrCl≥30mL/min (Cockcroft-Gault formula, excluding acute declines).
- Coagulation: INR/PT ≤1.5×ULN.
- Meeting the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for systemic lupus erythematosus (SLE);
- Failure to achieve remission following treatment regimens comprising glucocorticoids and at least two immunosuppressive agents (including cyclophosphamide [CTX], tacrolimus, mycophenolate mofetil [MMF], and...
- Urine protein-to-creatinine ratio (UPCR) ≥1.0 g/g or 24-hour urine protein excretion \>1.0 g at screening.
- Renal pathology must be performed within 6 months prior to the screening visit or during the screening period, demonstrating proliferative lupus nephritis (Class III or IV, with or without Class V) according to the 2003...
- Meeting the 2002 American-European Consensus Group (AECG) criteria or the 2016 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for primary Sjögren's syndrome;
- Having a disease activity score of EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) ≥ 6;
- Testing positive for anti-SSA/Ro antibodies;
- Meeting the 2006 Sydney-revised diagnostic criteria for primary antiphospholipid syndrome;
- Testing positive for antiphospholipid antibodies at moderate to high titers (IgG/IgM antibodies against lupus anticoagulant, LA; beta-2 glycoprotein I, B2GP1
- Definition of relapsing/refractory condition: Recurrence of thrombosis despite standard treatment with warfarin anticoagulation or alternative vitamin K antagonist (i.e., maintaining the required international...
- For catastrophic antiphospholipid syndrome, the following four criteria must be met: (1) involvement of three or more organs, systems, and/or tissues; (2) onset of symptoms within one week
- Individuals with a severe history of drug allergies or those with an allergic constitution;
- Individuals with existing or suspected uncontrolled or treatable fungal, bacterial, viral, or other infections;
- people with central nervous system diseases (excluding those with a history of epilepsy, psychiatric disorders, organic brain disease syndromes, cerebrovascular accidents, encephalitis, or central nervous system...
- people whose cardiac function cannot tolerate the study interventions;
- people with congenital immunoglobulin deficiencies;
- people with a history of malignant tumors within the past five years;
- people with end-stage renal failure;
- people who are positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titers exceeding the upper limit of detection
- History of symptomatic deep vein thrombosis or pulmonary embolism within the 6 months prior to screening;
- people with psychiatric disorders or severe cognitive dysfunction;
- people who have participated in other clinical trials within the past three months prior to enrollment;
- people who have received immunosuppressive agents with therapeutic effects on the disease within five half-lives prior to enrollment or biological agents within four weeks prior to enrollment;
- Pregnant women or women planning to become pregnant;
- people whom the investigator believes have other reasons that preclude their inclusion in this study.
The study team makes the final eligibility decision.
Where it is enrolling
- Hefei, Anhui, 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, but 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 to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Hefei, Anhui, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.