Ignite Creation Date:
2024-05-06 @ 12:57 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03893019
Status:
TERMINATED
Last Update Posted:
2024-05-16
First Post:
2019-03-06
Brief Title:
MB-CART201 Melanoma
Sponsor:
Miltenyi Biomedicine GmbH
Organization:
Miltenyi Biomedicine GmbH
Study Overview
Official Title:
Multicenter Phase I Trial of MB-CART201 for the Treatment of Patients With Metastatic Melanoma
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
Recruiting
Delayed Posting:
No
If Stopped, Why?:
The risk-benefit assessment was not as expected
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 l multi-centric single arm prospective open dose-escalation study in patients with unresectable stage III oder IV melanoma The trial will include 15 adult patients The trial is a classic 33 design with 1 Log dose increments and maximum 3 dose levels of the intravenously administered MB-CART201
Detailed Description:
This Phase I trial will be the first trial with CD20 CAR transduced T cells in Europe targeting melanoma The rationale for the trial is based on the finding that melanoma cancer sustaining cells express CD20 and that targeting CD20 cells in preclinical model has a strong antitumor effect
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