Trial Title:
A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Participants With Aggressive B-cell Non-Hodgkin Lymphomas
NCT ID:
NCT05685173
Condition:
B-cell Non-Hodgkins Lymphoma (B-NHL)
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Aggression
Conditions: Keywords:
Aggressive B-Cell Non-Hodgkin Lymphomas
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Odronextamab
Description:
Odronextamab will be administered by IV infusion
Arm group label:
Odronextamab and REGN5837
Other name:
REGN1979
Intervention type:
Drug
Intervention name:
REGN5837
Description:
REGN5837 will be administered by IV infusion
Arm group label:
Odronextamab and REGN5837
Summary:
The study is researching an experimental drug called REGN5837 in combination with another
experimental drug, odronextamab. The aim of the study is to see how safe and tolerable
the study drugs are, and to define the recommended dose for phase 2 for the combination.
The study is focused on patients with relapsed or refractory aggressive B-cell
non-Hodgkin lymphomas (B-NHLs).
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drugs
- How much study drug is in your blood at different times
- Whether the body makes antibodies against the study drugs (that could make the drugs
less effective or could lead to side effects)
- To find out how well the study drugs work against relapsed or refractory aggressive
B-cell non-Hodgkin lymphomas (B-NHLs)
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
1. Have documented CD20+ aggressive B-NHL, with disease that has progressed after at
least 2 lines of systemic therapy containing an anti-CD20 antibody and an alkylating
agent.
2. Measurable disease on cross sectional imaging as defined in the protocol
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
4. Adequate bone marrow, renal and hepatic function as defined in the protocol
5. During dose expansion phase of the study, participant should be willing to undergo
mandatory tumor biopsies, if in the opinion of the investigator, the participant has
an accessible lesion that can be biopsied without significant risk to the
participant.
Key Exclusion Criteria:
1. Prior treatments with allogeneic stem cell transplantation or solid organ
transplantation, treatment with anti-CD20 x anti- CD3 bispecific antibody, such as
odronextamab
2. Diagnosis of mantle cell lymphoma (MCL)
3. Primary central nervous system (CNS) lymphoma or known involvement by non-primary
CNS lymphoma
4. Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 14
days prior to first administration of study drug, whichever is shorter
5. Standard radiotherapy within 14 days of first administration of study drug.
6. Continuous systemic corticosteroid treatment with more than 10 mg per day of
prednisone or corticosteroid equivalent within 72 hours of start of odronextamab
7. Co-morbid conditions, as described in the protocol
8. Infections, as described in the protocol
9. Allergy/hypersensitivity: Known hypersensitivity to both allopurinol and rasburicase
NOTE: Other protocol defined inclusion / exclusion criteria apply
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
Norton Cancer Institute
Address:
City:
Louisville
Zip:
40241
Country:
United States
Status:
Recruiting
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Facility:
Name:
Beth Israel Deaconess Medical Center (BIDMC)
Address:
City:
Boston
Zip:
02215-5400
Country:
United States
Status:
Recruiting
Facility:
Name:
Rutgers Cancer Institute of New Jersey.
Address:
City:
New Brunswick
Zip:
08903
Country:
United States
Status:
Recruiting
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08903
Country:
United States
Status:
Recruiting
Facility:
Name:
Laura and Isaac Perlmutter Cancer Center (NYU Cancer Institute (NYUCI)
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Suspended
Facility:
Name:
Icahn School of Medicine at Mount Sinai
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Texas (UT) - Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Facility:
Name:
Hopital Saint-Louis
Address:
City:
Paris
Zip:
75010
Country:
France
Status:
Recruiting
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Recruiting
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Erasmus Medical Center Rotterdam
Address:
City:
Rotterdam
Zip:
3015
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Amsterdam University Medical Center
Address:
City:
Amsterdam
Zip:
1100AZ
Country:
Netherlands
Status:
Active, not recruiting
Facility:
Name:
Hospital Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
University Hospital & Research Institute - Hospital 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Royal Cornwall Hospitals NHS Trust
Address:
City:
Truro
Zip:
TR1 3LQ
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Southampton General Hospital
Address:
City:
Southampton
Zip:
SO16 6YD
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
The Christie NHS Foundation Trust
Address:
City:
Withington
Zip:
M20 4BQ
Country:
United Kingdom
Status:
Recruiting
Start date:
April 12, 2023
Completion date:
May 16, 2029
Lead sponsor:
Agency:
Regeneron Pharmaceuticals
Agency class:
Industry
Source:
Regeneron Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05685173
