Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510491
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Epcoritamab in Previously Treated WM
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Trial Investigating Epcoritamab in Patients With Previously Treated Waldenstrom Macroglobulinemia WM
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being done to determine if epcoritamab can be used to treat participants with previously treated Waldenstrom Macroglobulinemia WM
The names of the study drug involved in this study is
-Epcoritamab a type of antibody
The names of the study drug involved in this study is
-Epcoritamab a type of antibody
Detailed Description:
This is a prospective phase 2 single arm open label trial to determine if epcoritamab can be used to treat participants with previously treated Waldenstrom Macroglobulinemia WM Epcoritamab is a bispecific antibody a synthetic protein that activates the immune system to target cancer cells
The US Food and Drug Administration FDA has not approved epcoritamab for WM
The research study procedures include screening for eligibility in-clinic visits questionnaires blood tests electrocardiograms bone marrow biopsies and Computerized Tomography CT scans
Participants will receive study treatment for up to 4 months and will be followed for 24 months
It is expected that about 20 people will take part in this research study
Genmab Inc is funding this research study by providing the study drug epcoritamab
The US Food and Drug Administration FDA has not approved epcoritamab for WM
The research study procedures include screening for eligibility in-clinic visits questionnaires blood tests electrocardiograms bone marrow biopsies and Computerized Tomography CT scans
Participants will receive study treatment for up to 4 months and will be followed for 24 months
It is expected that about 20 people will take part in this research study
Genmab Inc is funding this research study by providing the study drug epcoritamab
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None