Actively Recruiting
MB-CART19.1 in Refractory SLE
Led by Miltenyi Biomedicine GmbH · Updated on 2025-11-26
29
Participants Needed
3
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase l/ll open-label, multicentre, interventional single-arm trial of MB-CART19.1 in patients with refractory SLE systemic lupus erythematosus. In the phase I part, a maximum of n=12 patients will be treated in a maximum of 3 dose levels. In the phase IIa part, a maximum of n=17 will be treated (n=10 patients in a 1st stage + n=7 patients in a 2nd stage). This includes the patients from the phase I part treated on the recommended dose level.
CONDITIONS
Official Title
MB-CART19.1 in Refractory SLE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients at least 18 years of age.
- Signed and dated informed consent before any trial procedure.
- Diagnosis of SLE meeting 2019 ACR/EULAR criteria.
- Disease activity with one BILAG A or two BILAG B scores despite treatment with at least two listed medications.
- Major organ involvement: active lupus nephritis, heart involvement, or lung disease as defined by specified clinical criteria.
- Absolute CD3+ T cell count of at least 100/µl.
- Women must have no childbearing potential or a negative pregnancy test and agree to use contraception from screening until 12 months after treatment.
- Fully vaccinated against SARS-CoV-2 or confirmed infection within last 6 months.
You will not qualify if you...
- Active significant central nervous system dysfunction.
- Uncontrolled diabetes mellitus.
- Therapy-induced lung disease or tuberculosis.
- Lung function below specified thresholds.
- Neuropsychiatric SLE with BILAG A or BILAG B.
- History of malignancy unless disease-free for at least 5 years (except certain skin cancers).
- Unstable coronary heart disease or low left ventricular ejection fraction.
- Renal function with eGFR below 30 ml/min/1.73 m².
- Severe liver insufficiency (Child-Pugh score > 10).
- Known HIV infection or active hepatitis B.
- History of hepatitis C unless treated and PCR negative.
- Any active uncontrolled infection including SARS-CoV-2.
- History of stem cell or organ transplantation.
- Irreversible organ damage.
- Certain medications within defined timeframes before leukapheresis.
- Hypersensitivity to drugs used in the trial.
- Contraindications to trial procedures.
- Women of childbearing potential not agreeing to effective contraception or abstinence.
- Men with partners of childbearing potential not agreeing to contraception or abstinence.
- Participation in other interventional trials.
- Inability to understand trial procedures and risks.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Universitätsklinikum Erlangen, Medizinische Klinik 3
Erlangen, Germany
Not Yet Recruiting
2
Otto-von-Guericke-Universität Magdeburg
Magdeburg, Germany
Actively Recruiting
3
Universitatsklinikum Tubingen - Medizinische Universitätsklinik Abt. II
Tübingen, Germany
Actively Recruiting
Research Team
C
Clinical Trial Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here