SLE study: CD19 or CD19-BCMA CAR-T
Official title Clinical Study on Targeted CD19 or CD19-BCMA CAR-T Therapy for Autoimmune Diseases
ClinicalTrials.gov ID: NCT06548607
What this study is testing
What is CD19 or CD19-BCMA CAR‑T?
An investigational cell therapy being studied for the treatment of systemic lupus erythematosus (SLE) and other autoimmune diseases. is designed to modify a patient’s own T cells to target cells expressing the CD19 or BCMA protein.
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 looks at how safe and well patients tolerate the CAR‑T treatment, how the drug behaves in the body, and whether it shows any signs of working.
- Who it's for
- It is for adults who have active systemic lupus, systemic sclerosis, ANCA‑associated vasculitis, idiopathic inflammatory myopathies, or Sjögren’s syndrome.
- What's involved
- Participants receive a CAR‑T cell infusion and are monitored with blood tests, imaging, and clinical visits to track safety and effectiveness.
- 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 70
You may be able to join if
- The people voluntarily participated in the study and signed the informed consent form.
- Age ≥18 years old and ≤70 years old, both sexes.
- Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN), total bilirubin (TBIL) ≤2×ULN...
- Renal function: creatinine ≤1.5×ULN or creatinine clearance ≥40 ml/min.
- Blood routine: neutrophil count ≥1×10\^9/L, hemoglobin ≥60g/L, platelet count ≥20×10\^9/L, lymphocyte count \>0.3×10\^9/L.
You likely can't join if
- SLE Patients: Those with uncontrolled lupus crisis within the 8 weeks prior to screening, including rapidly progressive lupus nephritis, severe...
- IIM Patients: Presence of severe rhabdomyolysis or CK levels ≥120×ULN at screening.
- Patients with severe asthma or Chronic Obstructive Pulmonary Disease (COPD) are eligible.
- There has been an active infection requiring systemic treatment within 2 weeks prior to the urethral irrigation, such as infectious pneumonia...
- Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in...
- Pregnant or breastfeeding women.
See the full eligibility criteria
- The people voluntarily participated in the study and signed the informed consent form.
- Age ≥18 years old and ≤70 years old, both sexes.
- Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN), total bilirubin (TBIL) ≤2×ULN (except Gilbert's syndrome).
- Renal function: creatinine ≤1.5×ULN or creatinine clearance ≥40 ml/min.
- Blood routine: neutrophil count ≥1×10\^9/L, hemoglobin ≥60g/L, platelet count ≥20×10\^9/L, lymphocyte count \>0.3×10\^9/L.
- Coagulation: international normalized ratio (INR) ≤ 1.5×ULN, or prothrombin time (PT) ≤ 1.5×ULN.
- Oxygen saturation (SpO2) ≥92% at rest in room air.
- Left ventricular ejection fraction (LVEF) ≥50% on echocardiography.
- Negative serum or urine pregnancy test results in female people of childbearing potential at screening.
- Women of childbearing potential must agree to use a highly effective method of contraception for at least 28 days before initiation of elution and up to 12 months after CAR-T reinfusion.
- A definitive diagnosis of SLE according to the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus International Collaborating...
- Positive antinuclear antibodies (ANA) at screening, and/or positive anti-double-stranded DNA (anti-dsDNA) antibodies, and/or positive anti-Smith antibodies.
- A SLEDAI-2K score \>6 at screening, and a 'clinical' SLEDAI-2K score ≥4. SSc Patient
- Diagnosed with SSc according to the 2013 ACR/EULAR classification criteria.
- Diagnosed with diffuse cutaneous SSc at screening, with a disease duration ≤6 years. AAV Patient
- Meeting the diagnostic criteria for ANCA-associated vasculitis established by the 2022 ACR/EULAR, including Microscopic Polyangiitis (MPA), Granulomatosis with Polyangiitis (GPA), and Eosinophilic Granulomatosis with...
- Positive testing for ANCA-associated antibodies 3 months before screening or at screening (specifically, positive anti-myeloperoxidase antibodies, MPO-ANCA, or positive anti-proteinase 3 antibodies, PR3-ANCA).
- Diagnosed with IIM according to the 2017 ACR/EULAR classification criteria (including probable or definite diagnosis, i.e., probability ≥55%), including subtypes such as Dermatomyositis (DM), Anti-Synthetase Syndrome...
- Patients in the active phase, defined as those with at least 2 of the following six core set measures being abnormal: decreased muscle strength (MMT-8 \<142), Physician Global Assessment (PhGA, 10cm VAS) ≥2cm, Patient...
- Diagnosed with primary Sjögren's Syndrome according to the 2016 ACR/EULAR classification criteria.
- Positive for anti-SSA/Ro antibodies detected 3 months before screening or at screening.
- A score of ≥5 on the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) at screening.
- SLE Patients: Those with uncontrolled lupus crisis within the 8 weeks prior to screening, including rapidly progressive lupus nephritis, severe neuropsychiatric lupus, severe hemolytic anemia, severe immune...
- IIM Patients: Presence of severe rhabdomyolysis or CK levels ≥120×ULN at screening.
- Patients with severe asthma or Chronic Obstructive Pulmonary Disease (COPD) are eligible. Patients with mild or moderate asthma or COPD who are receiving stable treatment can also be enrolled.
- There has been an active infection requiring systemic treatment within 2 weeks prior to the urethral irrigation, such as infectious pneumonia, tuberculosis, etc.
- Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood
- Pregnant or breastfeeding women.
- Any condition that, in the investigator's opinion, may affect study participation, pose a safety risk to the patient, or potentially confound the interpretation of study results.
The study team makes the final eligibility decision.
Where it is enrolling
- Bengbu, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bengbu, 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.