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MB-CART19.1 in Refractory SLE

NCT06189157 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-11-26

No results posted yet for this study

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.

Conditions

  • SLE - Systemic Lupus Erythematosus

Interventions

BIOLOGICAL

MB-CART19.1

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

Sponsors & Collaborators

  • Miltenyi Biomedicine GmbH

    lead INDUSTRY

Principal Investigators

  • Georg Schett, Prof. Dr. · University Clinical Erlangen, Medical Clinic 3

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-12
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06189157 on ClinicalTrials.gov