NCT06189157
MB-CART19.1 in Refractory SLE
Recruiting · Phase 1, Phase 2 · Miltenyi Biomedicine GmbH · registry updated 2025-11-26
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- Patients at least 18 years of age.
- Signed and dated informed consent before the conduct of any trial-specific procedure.
- SLE fulfilling the 2019 ACR/EULAR classification criteria (refer to Appendix 8).
- One BILAG A or two BILAG B despite treatment with at least two of the following treatment options: MMF, cyclophosphamide, rituximab belimumab, anifrolumab, methotrexate, azathioprine.
- SLE with major organ involvement defined as either:
- Presence of active lupus nephritis according to the following criteria:
Exclusion
- Active clinically significant central nervous system (CNS) dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis).
- Uncontrolled diabetes mellitus.
- Therapy induced lung disease and tuberculosis.
- Forced Vital Capacity (FVC) \< 60 %, FEV1 \< 60 %, Total Lung Capacity (TLC) \< 60 % and DLCO (diffusion capacity) \< 60 %.
- BILAG A or BILAG B for neuropsychiatric SLE.
- History of a malignancy unless disease free for ≥ 5 years with the exception of basal or squamous cell skin cancer.