Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06189157
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-11-22
Brief Title:
MB-CART191 in Refractory SLE
Sponsor:
Miltenyi Biomedicine GmbH
Organization:
Miltenyi Biomedicine GmbH
Study Overview
Official Title:
An Open-label Phase IIIa Multicentre Interventional Single-arm Trial of MB-CART191 in Patients with Refractory SLE
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase lll open-label multicentre interventional single-arm trial of MB-CART191 in patients with refractory SLE systemic lupus erythematosus In the phase I part a maximum of n12 patients will be treated in a maximum of 3 dose levels
In the phase IIa part a maximum of n17 will be treated n10 patients in a 1st stage n7 patients in a 2nd stage This includes the patients from the phase I part treated on the recommended dose level
In the phase IIa part a maximum of n17 will be treated n10 patients in a 1st stage n7 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 SARAESI 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
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 SARAESI 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None