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New treatment option for B-cell Non-Hodgkins Lymphoma (B-NHL)
Official title A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas
ClinicalTrials.gov ID: NCT05685173
What this study is testing
What is Odronextamab?
Odronextamab is an investigational medicine, being studied as a potential treatment for b-cell non-hodgkins lymphoma (b-nhl).
Also referred to as REGN1979, Ordspono™.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is researching an experimental drug called REGN5837 in combination with another drug, odronextamab (called "study drug(s)"), in patients with relapsed or refractory aggressive B-cell Non-Hodgkin Lymphomas (B-NHLs). The study has 2 parts.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Have documented CD20+ aggressive B-NHL, with disease that has progressed after at least 2 lines of systemic therapy containing an anti-CD20 antibody...
- Measurable disease on cross sectional imaging as defined in the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate bone marrow, renal and hepatic function as defined in the protocol
- Availability of tumor tissue for submission to central laboratory is required for study enrollment. Archival tumor tissue for histological assessment...
You likely can't join if
- Prior treatments with allogeneic stem cell transplantation or solid organ transplantation, treatment with anti-CD20 x anti- CD3 bispecific antibody...
- Diagnosis of Mantle Cell Lymphoma (MCL)
- Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS lymphoma, as described in the protocol
- Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 14 days prior to first administration of study drug, whichever is...
- Standard radiotherapy within 14 days of first administration of study drug, as described in the protocol
- Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or corticosteroid equivalent within 72 hours of start of...
See the full eligibility criteria
- 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, as described in the protocol.
- Measurable disease on cross sectional imaging as defined in the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate bone marrow, renal and hepatic function as defined in the protocol
- Availability of tumor tissue for submission to central laboratory is required for study enrollment. Archival tumor tissue for histological assessment prior to enrollment is allowed
- 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...
- Prior treatments with allogeneic stem cell transplantation or solid organ transplantation, treatment with anti-CD20 x anti- CD3 bispecific antibody, such as odronextamab
- Diagnosis of Mantle Cell Lymphoma (MCL)
- Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS lymphoma, as described in the protocol
- 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, as described in the protocol
- Standard radiotherapy within 14 days of first administration of study drug, as described in the protocol
- Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or corticosteroid equivalent within 72 hours of start of odronextamab
- Co-morbid conditions, as described in the protocol
- Infections, as described in the protocol
- Allergy/hypersensitivity: Known hypersensitivity to both allopurinol and rasburicase NOTE: Other protocol defined inclusion / exclusion criteria apply
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Santa Monica, California, United States
- Louisville, Kentucky, United States
- Boston, Massachusetts, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- Dallas, Texas, United States
- Talence, New Aquitaine, France
- Paris, France
- Villejuif, Île-de-France Region, France
- Rotterdam, South Holland, Netherlands
- Amsterdam, Netherlands
- Barcelona, Spain
- Madrid, Spain
- Truro, Cornwall, United Kingdom
- Southampton, Hampshire, United Kingdom
- Edinburgh, Scotland, United Kingdom
- Manchester, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Santa Monica, California, United States; Louisville, Kentucky, United States; Boston, Massachusetts, United States; New Brunswick, New Jersey, United States; New York, New York, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.