NCT06189157

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Miltenyi Biomedicine GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients will be treated in cohorts of 3. After each cohort, the Safety Monitoring Board (SMB) will meet to assess whether the next higher dose level can be opened. The follow-up of the patients will be performed in 3 steps: * Until day 28 after treatment, the patients will be followed up closely by monitoring vital functions and lab parameters for signs of AEs and DLTs. Blood samples for the determination of persistence and phenotype of infused CAR+ cells will be taken. B cell aplasia in peripheral blood will be determined together with other secondary and exploratory biomarkers, response will be assessed and AEs will be documented. * In the second follow-up phase until 1 year, blood samples for the determination of persistence and phenotype of infused CAR+ cells will be taken, B cell aplasia will be determined, response will be assessed and AEs will be documented until end of week 12, afterwards serious AEs (SAE) and AEs of special interest (AESI) will be documented, serious adverse reactions (SAR)/AESI will be reported. * All patients irrespective of the clinical response will be followed up then for 1 more year or until the patient is lost to follow-up or has died. After completion of this last follow-up phase, patients will be rolled over to a subsequent follow-up observation for up to further 13 years.

Conditions

• SLE - Systemic Lupus Erythematosus

Interventions

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

Timeline

• Start date: 2024-08-12
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2024-01-03
• Last updated: 2025-11-26

Locations

3 sites across 1 country: Germany