Actively Recruiting
CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease
Led by Miltenyi Biomedicine GmbH · Updated on 2025-09-30
24
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The investigational product is designed to effectively combat B cells in patients with autoimmune diseases. Autologous T cells enriched with CD4/CD8 are genetically engineered using a lentiviral vector to express chimeric antigen receptors (CARs) that target the CD19 antigen on the cell surface of B cells and their precursors. During treatment, patients undergo leukapheresis, lymophodepleting chemotherapy and administration of the expanded CD19-CAR-transduced T cells.
CONDITIONS
Official Title
CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older at time of consent
- Able to understand and voluntarily sign informed consent including data protection agreement
- Adequate kidney (eGFR > 30 ml/min/m2), liver (not Child Pugh C), heart (NYHA III or better, EF > 30%), and lung function (FV and DLCO > 30%)
- Male participants must be surgically sterile or agree to use two effective contraception methods during the study and for 12 months after treatment
- Females of childbearing potential must test negative for pregnancy at screening and agree to use highly effective contraception during the study and for 12 months after treatment
- Must be able to follow study visit schedule and protocol requirements
- Have received double vaccination against SARS-CoV-2 or SARS-CoV-2 vaccination within the last 6 months
- For SLE: meet 2019 ACR/EULAR criteria, have positive relevant antibodies, active disease with specified BILAG scores, and insufficient response or intolerance to glucocorticoids and at least two specified treatments
- For SSc: meet 2013 ACR/EULAR criteria, positive for at least one specific antibody, signs of fast disease progression, and insufficient response or intolerance to at least two specified treatments
- For DM/PM: meet 2017 ACR/EULAR criteria, active myositis or related lung disease, positive for at least one myositis-specific antibody, muscle weakness as defined, and insufficient response or intolerance to glucocorticoids and at least two specified treatments
You will not qualify if you...
- Suitable for less burdensome or approved therapy as judged by investigator
- Low blood cell counts (ANC < 1000/mm3, ALC < 500/mm3, hemoglobin < 8g/dl, CD3+ T cells < 100/μl)
- Uncontrolled serious diseases such as cancer (except certain skin cancers) or diabetes
- Severely impaired kidney (eGFR ≤ 30 ml/min/m2), liver (Child Pugh C), heart (NYHA IV, EF ≤ 30%), or lung function (FV and DLCO ≤ 30%)
- Any condition or lab abnormality that poses unacceptable risk or confounds study data
- Prior treatment with anti-CD19 antibody, adoptive T cell therapy, or gene therapy (including CAR T cells)
- History of bone marrow, stem cell, or organ transplantation
- Severe active infections like HIV, hepatitis B or C, COVID-19, or active tuberculosis
- Severe neuropsychiatric SLE, inclusion body myositis, or limited systemic sclerosis
- Pregnant or breastfeeding females
- Females intending to conceive during the study
- Known allergy to study drug components
- Cancer within last 5 years
- Need for live vaccine during study or within 14 days before leukapheresis
- Under 18 years old or unable to understand study and give informed consent
- History of alcohol or substance abuse in last 6 months that may increase risk or affect results
- Possible dependence on study staff or sponsor (e.g., family members)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany, 91054
Actively Recruiting
Research Team
G
Georg Schett, Prof. Dr. med. univ.
CONTACT
D
Daniela Bohr, Dr.med
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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