Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-28 @ 8:44 AM
Study NCT ID:
NCT06510361
Status:
RECRUITING
Last Update Posted:
2025-08-19
First Post:
2024-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a CR With Upfront Chemoimmunotherapy
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Study Overview
Official Title:
A Phase 2 Study of Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a Complete Response With Upfront Chemoimmunotherapy
Status:
RECRUITING
Status Verified Date:
2025-08
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:
This research is being done to see if epcoritamab is effective in treating follicular lymphoma as a second line of treatment.
The name of the study drug in this research study is:
-Epcoritamab (a type of antibody)
The name of the study drug in this research study is:
-Epcoritamab (a type of antibody)
Detailed Description:
This is a prospective, phase 2, single arm, open label trial investigating epcoritamab in participants with follicular lymphoma (FL) who have failed to achieve a complete response after frontline therapy. Epcoritamab is a bispecific antibody, a synthetic protein that activates the immune system to target cancer cells.
The U.S. Food and Drug Administration (FDA) has not approved epcoritamab for follicular lymphoma but it has been approved for other uses.
The research study procedures include screening for eligibility, treatment study visits, questionnaires, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, Positron Emission Tomography (PET) scans, electrocardiograms, blood tests, and bone marrow biopsies.
Participants will receive treatment for up to 12 cycles and will be followed for 2 years.
It is expected that about 35 people will take part in this research study.
Genmab, Inc. is funding this research study by providing the study drug, Epcoritamab.
The U.S. Food and Drug Administration (FDA) has not approved epcoritamab for follicular lymphoma but it has been approved for other uses.
The research study procedures include screening for eligibility, treatment study visits, questionnaires, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, Positron Emission Tomography (PET) scans, electrocardiograms, blood tests, and bone marrow biopsies.
Participants will receive treatment for up to 12 cycles and will be followed for 2 years.
It is expected that about 35 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:
True
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?:
True
Is an FDA AA801 Violation?: