Viewing Study NCT03853616



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Last Modification Date: 2024-10-26 @ 1:04 PM
Study NCT ID: NCT03853616
Status: RECRUITING
Last Update Posted: 2024-06-21
First Post: 2019-02-19

Brief Title: MB-CART191 Rr CD19 B-cell Malignancies BCM
Sponsor: Miltenyi Biomedicine GmbH
Organization: Miltenyi Biomedicine GmbH

Study Overview

Official Title: A Phase III Safety Dose Finding and Feasibility Trial of MB-CART191 in Patients with Relapsed or Refractory CD19 Positive B Cell Malignancies
Status: RECRUITING
Status Verified Date: 2024-10
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 multi-centric single arm prospective open dose-escalation study in patients with relapsed or refractory CD19-positive B cell malignancies ALL NHL CLL The trial will include adult and pediatric patients The trial consists of 2 parts Part I and Part II In total approximately 48 patients will be included in Part I of the trial There will be three individual cohorts defined by disease biology pediatric ALL and aggressive pediatric NHL Cohort 1 adult ALL Cohort 2 and adult NHLCLL Cohort 3
Detailed Description: The Part I Phase I will evaluate the safety of the MB-CART191 and determine the recommended dose levels for the Part II Phase II efficacy evaluation in each of the three disease cohorts

Dose evaluation will start in Cohorts 1 and 2 with Dose Level 1 and in Cohort 3 with Dose Level 2 sparing Dose Level 1 see figure 1 Each of the cohorts will evaluate the safety of MB-CART191

In each dose level of each of the three cohorts three 3 3 patients will be treated A particular dose level will be expanded to 6 patients if one patient out of 3 patients treated at that particular dose level develops DLT Once this occurs further dose-escalations are halted until the dose has proven to be safe in the expanded cohort If 2 or more in a cohort of 6 patients develop DLT no further dose escalation is allowed and the next lower dose level will be expanded to 6 patients in total The highest dose among the dose levels tested at which no more than one out of six patients experiences DLT will be considered the MTD In Dose Level 3 three additional patients will be treated if no DLT occurred Dose Level 0 will be tested only if Dose Level 1 is not tolerable

Cohort 3 will Start with Dose Level 2 If Dose Level 2 is not tolerated Dose Level 1 will be tested DLT will be evaluated within 4 weeks after the infusion of MB-CART191 An interval of at least 28 days between the treatment of the first and the second patient in each dose level and in each cohort is mandatory

Part II Phase II will evaluate the efficacy and safety in patients treated with the recommended dose in Cohorts 1 to 3 respectively After review of completed day 28 safety and efficacy data within Part I Phase I by the SMB the design of Phase II specifically the number and types of Phase II cohorts and the recommended dose levels for Phase II will be determined and thus the number of patients to be treated will be calculated

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
Secondary IDs
Secondary ID Type Domain Link
2017-002848-32 EUDRACT_NUMBER None None