Clinical Trial

MB-CART19.1 in Refractory SLE

Recruiting Phase 1/2
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-12-19; most recent amendment 2025-11-20.
Status change: Not Yet Recruiting → Recruiting 2024-09-02
Trial Details
NCT Number NCT06189157
Lead Sponsor Miltenyi Biomedicine GmbH
Conditions SLE - Systemic Lupus Erythematosus
Enrollment 29 participants
Start Date 2024-08-12
Primary Completion 2027-09-30 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-11-26