RecruitingPhase 1Phase 2NCT06189157

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


Sponsor

Miltenyi Biomedicine GmbH

Enrollment

29 participants

Start Date

Aug 12, 2024

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called MB-CART19.1 for people with sle - systemic lupus erythematosus. The study is currently recruiting participants at 3 locations.

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

BIOLOGICALMB-CART19.1

MB-CART19.1 consists of autologous CD19 Chimeric Antigen Receptor (CAR) transduced CD4/CD8 enriched T cells


Locations(3)

Universitätsklinikum Erlangen, Medizinische Klinik 3

Erlangen, Germany

Otto-von-Guericke-Universität Magdeburg

Magdeburg, Germany

Universitatsklinikum Tubingen - Medizinische Universitätsklinik Abt. II

Tübingen, Germany

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NCT06189157


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