Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04792489
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2021-02-25
Brief Title:
DALY II USA MB-CART20191 for DLBCL
Sponsor:
Miltenyi Biomedicine GmbH
Organization:
Miltenyi Biomedicine GmbH
Study Overview
Official Title:
A Multi-center Single Arm Phase II Study to Evaluate the Safety and Efficacy of Genetically Engineered Autologous Cells Expressing Anti-CD20 and Anti-CD19 Specific Chimeric Antigen Receptor in Subjects With Relapsed andor Refractory Diffuse Large B Cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-04
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:
DALY II USA is a phase II multi-center single arm study to evaluate the efficacy safety and pharmacokinetics of zamtocabtagene autoleucel MB-CART20191 in patients with relapsed andor refractory diffuse large B cell lymphoma DLBCL after receiving at least two lines of therapy
Detailed Description:
A prospective single arm open label multi-center phase II study of autologous T cells engineered against both CD19 and CD20 antigens for subjects with relapsed or refractory DLBCL after receiving at least two lines of therapy The investigational agent is the MB-CART20191 cells After successful screening subjects will undergo leukapheresis to collect product for manufacturing In preparation for the fresh product infusion subjects will undergo a lymphodepleting regimen with cyclophosphamide and fludarabine or bendamustine Cell infusion will be administered intravenously at a dose of 25 x 106 CAR cellskg body weight The study will start with enrollment of 3 subjects in the lead-in safety phase and after safety is evaluated the study will continue with enrollment of the remaining subjects Subjects will be followed for up to 2 years for efficacy and safety outcomes as well as health-related quality of life HRQol Additional long-term follow-up will be conducted for participants under a separate long-term follow-up protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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