MB-CART19.1 in Refractory SLE
ConditionSLE - Systemic Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMiltenyi Biomedicine GmbH
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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 %.
Trial design
Treatments tested in this trial
- MB-CART19.1
Treatment groups
29 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov