Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424340
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-16
Brief Title:
MB-dNPM1-TCR1 in RelapsedRefractory AML
Sponsor:
Miltenyi Biomedicine GmbH
Organization:
Miltenyi Biomedicine GmbH
Study Overview
Official Title:
A Phase III Trial of MB-dNPM1-TCR1 in HLA-A0201-positive Patients With Relapsed or Refractory NPM1-mutated AML to Determine Safety and Obtain First Data on Efficacy
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The goal of this Phase III single arm prospective open label dose escalation trial is to assess safety feasibility and efficacy of ex vivo expanded autologous T cells genetically modified to express a T cell receptor TCR specific for dNPM1 peptides restricted to human leukocyte antigen HLA A0201 in patients with relapsed or refractory AML
Detailed Description:
The investigational medicinal product IMP MB-dNPM1-TCR1 is designed to effectively target malignant myeloid cells in patients suffering from relapsed or refractory Acute Myeloid Leukemia AML with mutated Nucleophosmin Autologous T cells will be genetically engineered using a lentiviral vector to express a T cell receptor TCR specific for certain dNPM1 peptides restricted to human leukocyte antigen HLA A0201 The dNPM1-TCR transduced T cells target specifically the HLAdNPM1 peptide complex on the cell surface of leukemic myeloid cells and eliminate these During the treatment the patients will undergo a leukapheresis a lymphodepleting chemotherapy and an administration of the expanded dNPM1-TCR transduced T cells
Phase I Since this is a first in human trial the primary goal in phase I is to establish the recommended dose of MB-dNPM1-TCR1 for phase II We assess the maximum tolerated dose MTD with toxicity defined as patients experiencing dose limiting toxicity DLT until day 28 after infusion of MB-dNPM1-TCR1 Therefore a BOIN trial design will be used to guide dose escalation and de-escalation decisions in phase I
Phase II The second phase will evaluate the efficacy and safety in patients treated with the recommended dose from phase I The phase II part follows a Simons minimax two stage design
Phase I Since this is a first in human trial the primary goal in phase I is to establish the recommended dose of MB-dNPM1-TCR1 for phase II We assess the maximum tolerated dose MTD with toxicity defined as patients experiencing dose limiting toxicity DLT until day 28 after infusion of MB-dNPM1-TCR1 Therefore a BOIN trial design will be used to guide dose escalation and de-escalation decisions in phase I
Phase II The second phase will evaluate the efficacy and safety in patients treated with the recommended dose from phase I The phase II part follows a Simons minimax two stage design
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