MB-CART19.1 in Refractory SLE
An Open-label Phase I/IIa, Multicentre, Interventional Single-arm Trial of MB-CART19.1 in Patients With Refractory SLE
Miltenyi Biomedicine GmbH
29 participants
Aug 12, 2024
INTERVENTIONAL
Conditions
Summary
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
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
MB-CART19.1 consists of autologous CD19 Chimeric Antigen Receptor (CAR) transduced CD4/CD8 enriched T cells
Locations(3)
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NCT06189157