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Tests treatment safety and results for SLE (Systemic Lupus)
Official title Safety and Efficacy of CD19 Targeted CAR-T Therapy for Refractory Autoimmune Disease
ClinicalTrials.gov ID: NCT06056921
What this study is testing
What is CD19 targeted CAR-T cells?
CD19 targeted CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sle (systemic lupus).
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
- This is a single arm study to evaluate the efficacy and safety of CD19 targeted CAR-T cells therapy for patients with Refractory Autoimmune Disease
- 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
- ≥18 years old, male or female;
- diagnosed with one of the following diseases:
- Systemic Lupus Erythematosus (SLE), EULAR/ACR 2019 standard;
- Sjogren's Syndrome (SS), 2016 ACR/EULAR standard;
- Systemic Scleroderma (SSc), 2013 ACR/EULAR Standards;
You likely can't join if
- Had previously received CAR T cell therapy;
- patients with serious heart, liver, lung, blood system, endocrine system diseases, and the risk of participating in the trial is higher than the...
- There is an active or uncontrollable infection that requires systemic treatment within 1 week prior to screening;
- have previously received hematopoietic stem cell transplantation or solid organ transplantation (except corneal and hair transplantation), or have...
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than...
- Had received live vaccine within 4 weeks before screening;
See the full eligibility criteria
- ≥18 years old, male or female;
- diagnosed with one of the following diseases:
- Systemic Lupus Erythematosus (SLE), EULAR/ACR 2019 standard;
- Sjogren's Syndrome (SS), 2016 ACR/EULAR standard;
- Systemic Scleroderma (SSc), 2013 ACR/EULAR Standards;
- Dermatomyositis (DM), 2017 EULAR/ACR classification standard + one positive myositis specific antibody (Jo-1, Zo, EJ, PL-7, KS, OJ, PL-12, YRS, Anti-NXP-2, Anti-TIF1g, Anti-Mi-2, Anti-SAE, Anti-MDA-5, Anti-SRP...
- Anti-neutrophil cytoplasmic antibody associated vasculitis (ANCA-AAV), including granulomatosis with polyangiitis (GPA), or microscopic vasculitis (MPA), or eosinophilic granulomatosis with polyangiitis (EGPA), 2022...
- Disease activity meets the following requirements:
- SLEDAI score ≥8 for SLE patients;
- For SS patients, ESSDAI≥14 points;
- For patients with SSc, mRSS score in the range of 10-35 (including the boundary value) with interstitial pneumonia (ILD);
- Patients with DM who have been diagnosed for at least 1 year and meet the following conditions: 1\. Skin rash VAS score (based on MDAAT) ≥3cm with at least 3 abnormalities in CSM; 2, muscle biopsy pathology or muscle...
- For ANCA-AAV patients, the BVAS score was ≥15.
- ECOG 0\~1 score;
- The functions of important organs are basically normal:
- Hematology: hemoglobin ≥60g/L, platelet count ≥30×109/L;
- Cardiac function: Left ventricular ejection fraction (LVEF) ≥55%, no obvious abnormality in electrocardiogram;
- Renal function: eGFR≥30ML/min/1.73m2;
- Liver function: AST and ALT≤3.0 ULN, total bilirubin ≤2.0 ULN;
- Lung function: DLCO≥40% predicted value; FVC≥50% expected value;
- Have criteria for simple or intravenous blood collection, and no other contraindications for cell collection;
- The subject of childbearing age has a negative urine pregnancy test result and agrees to take effective contraceptive measures during the test period until 1 year after the infusion;
- The patient or his/her guardian agrees to participate in the clinical trial and signs the informed consent, indicating that he/she understands the purpose and procedure of the clinical trial and is willing to...
- Had previously received CAR T cell therapy;
- patients with serious heart, liver, lung, blood system, endocrine system diseases, and the risk of participating in the trial is higher than the benefit judged by the researcher;
- There is an active or uncontrollable infection that requires systemic treatment within 1 week prior to screening;
- have previously received hematopoietic stem cell transplantation or solid organ transplantation (except corneal and hair transplantation), or have grade 2 or higher acute graft-versus-host disease (GVHD) within 2 weeks...
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody...
- Had received live vaccine within 4 weeks before screening;
- pregnancy test positive;
- Patients with malignant diseases such as malignant tumors before screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery...
- Patients who had participated in other clinical trials within 3 months prior to screening;
- Situations in which other investigators consider it inappropriate to participate in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Taiyuan, Shanxi, 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 Taiyuan, Shanxi, 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.