A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma
Launched by REGENERON PHARMACEUTICALS · Jan 18, 2024
Trial Information
Current as of October 30, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying an experimental drug called odronextamab to see how effective and safe it is for adults with aggressive B-cell non-Hodgkin lymphoma (B-NHL) that has not responded to previous treatments or has come back after treatment. The trial aims to find out how well this drug works compared to the usual care patients receive. Researchers will also look at potential side effects, how the drug behaves in the body, and how it affects patients' quality of life and daily activities.
To be eligible for this trial, participants must be adults aged 65 or older who have been diagnosed with aggressive B-NHL and have already received at least one prior treatment that included a specific type of antibody. They should have measurable disease with certain sized tumors and plan to undergo a specific type of stem cell transplant. Participants can expect to receive the study drug and will be monitored closely for any side effects or changes in their condition. This trial is currently recruiting participants, and there are additional criteria that need to be met for enrollment.
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • 1. Histologically proven aggressive B-NHL, as described 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
- • 2. Have primary refractory or relapse 12 months or less (≤) from initiation of frontline therapy Only patients who received 1 prior line of therapy containing an anti-Cluster of Differentiation 20 (CD20) antibody and anthracycline are allowed for enrollment
- • 3. Have measurable disease with at least one nodal lesion with longer diameter (LDi) greater than 1.5 cm or at least one extranodal lesion with LDi greater than 1.0 cm, documented by diagnostic imaging (computed tomography \[CT\] or magnetic resonance imaging \[MRI\])
- • 4. Intent to proceed to autologous stem cell transplant (ASCT), as described in the protocol
- • 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- • 6. Adequate hematologic and organ function.
- Key Exclusion Criteria:
- • 1. Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL, as described in the protocol
- • 2. History of or current relevant CNS pathology, as described in the protocol
- • 3. A malignancy other than NHL unless the participant is adequately and definitively treated and is cancer free for at least 3 years, with the exception of localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that was definitively treated
- • 4. Any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol
- • 5. Wash-out period from prior anti-lymphoma treatments and infections, as described in the protocol
- • 6. Allergy/hypersensitivity to study drug, or excipients.
- • NOTE: Other protocol defined inclusion / exclusion criteria apply
About Regeneron Pharmaceuticals
Regeneron Pharmaceuticals, a leading biotechnology company, is dedicated to transforming the lives of patients through innovative medicines. Founded in 1988, the company specializes in the discovery, development, and commercialization of cutting-edge therapies for serious diseases, leveraging advanced genetic technologies and a robust pipeline of novel drug candidates. With a strong focus on areas such as ophthalmology, oncology, immunology, and rare diseases, Regeneron is committed to scientific excellence and collaboration, striving to deliver safe and effective treatments that address unmet medical needs and improve patient outcomes globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Valencia, Spain
Liverpool, New South Wales, Australia
Brisbane, Queensland, Australia
Hobart, Tasmania, Australia
Singapore, Singapore
Singapore, Singapore
Khon Kaen, Thailand
Woolloongabba, Queensland, Australia
Curitiba, Brazil
Madrid, Spain
Granada, Spain
Chiang Mai, Thailand
Madrid, Spain
Taichung, Taiwan
Taipei, Taiwan
Sevilla, Spain
Kota Kinabalu, Sabah, Malaysia
Tainan, Taiwan
Kaohsiung, Taiwan
Porto Alegre, Rio Grande Do Sul, Brazil
Singapore, Singapore
Tainan, Taiwan
Seoul, Korea, Republic Of
Changhua, Taiwan
Taipei, Taiwan
Busan, Korea, Republic Of
Subang Jaya, Selangor, Malaysia
Novara, Italy
Bangkok, Thailand
Brescia, Italy
Varese, Italy
Taipei City, Taiwan
Pamplona, Navarra, Spain
Pamplona, Spain
Izmir, Turkey
Porto Alegre, Rio Grande Do Sul, Brazil
Tainan City, Taiwan
Taipei City, Taiwan
São Paulo, Brazil
Izmir, Turkey
Valencia, Spain
Madrid, Spain
Madrid, Spain
Busan, Korea, Republic Of
Kaohsiung, Taiwan
New Taipei City, Taiwan
Daegu, Korea, Republic Of
Yangsan, Gyeongsangnam Do, Korea, Republic Of
Ulsan, Korea, Republic Of
Ampang, Selangor, Malaysia
Sao Paulo, Brazil
Meldola, Forli Cesena, Italy
Madrid, Spain
Terrassa, Barcelona, Spain
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Chiayi City, Taiwan
Pozuelo De Alarcón, Madrid, Spain
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Pozuelo De Alarcon, Madrid, Spain
Incheon, Namdong Gu, Korea, Republic Of
Daegu, Korea, Republic Of
Novara, Italy
Pamplona, Navarre, Spain
Curitiba, Parana, Brazil
Madrid, Spain
São Paulo, Brazil
Istanbul, Turkey
New Taipei City, Taiwan
Suwon Si, Gyeonggi Do, Korea, Republic Of
Pécs, Baranya, Hungary
Sevilla, Andalusia, Spain
Varese, Italy
Jeonju, Korea, Republic Of
Palma, Balearic Islands, Spain
Changhua City, Taiwan
Bangkok, Thailand
Samsun, Turkey
Madrid, Spain
Tekirdag, Suleymanpasa, Turkey
São Paulo, Brazil
Granada, Spain
Valencia, Spain
Terrassa, Barcelona, Spain
Palma, Palma De Mallorca, Spain
Serdivan, Sakarya, Turkey
Heidelberg, Victoria, Australia
Bangkok, Thailand
Daegu, Korea, Republic Of
Tekirdag, Suleymanpasa, Turkey
Ankara, Turkey
Taoyuan, Guishan District, Taiwan
Busan, Korea, Republic Of
Taoyuan, Taiwan
Suwon Si, Gyeonggi Do, Korea, Republic Of
Heidelberg, Victoria, Australia
Seoul, Korea, Republic Of
Johor Bahru, Johor, Malaysia
Seoul, Korea, Republic Of
Brescia, Italy
Incheon, Namdong Gu, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Aviano, Italy
Aviano, Pordenone, Italy
Ankara, Turkey
Kota Kinabalu, Sabah, Malaysia
Palma, Palma De Mallorca, Spain
Taipei City, Neihu, Taiwan
Taoyuan, Toayuan District, Taiwan
Zonguldak, Turkey
Rotterdam, Netherlands
Subang Jaya, Selangor, Malaysia
Samsun, Turkey
Mezitli, Mersin, Turkey
Meldola (Fc), Forli Cesena, Italy
Sakarya, Turkey
Heidelberg, Victoria, Australia
Seoul, Korea, Republic Of
Johor Bahru, Johor, Malaysia
Kuala Lumpur, Selangor, Malaysia
Chiayi City, Chianan Plain, Taiwan
Taichung, Taiwan
Ankara, Central Anatolia, Turkey
Kaohsiung City, Taiwan
Suwon Si, Gyeonggi Do, Korea, Republic Of
Seoul, Korea, Republic Of
Zonguldak, Turkey
Meldola, Forli Cesena, Italy
Porto Alegre, Rio Grande Do Sul, Brazil
Taoyuan, Taiwan
Sao Paulo, Brazil
Jau, Sao Paulo, Brazil
Salvador, Bahia, Brazil
Sakarya, Turkey
Cluj Napoca, Cluj, Romania
Changhua City, Taiwan
Salvador, Bahia, Brazil
Rio De Janeiro, Brazil
Taoyuan, Hunan Province, Taiwan
Aviano, Province Of Pordenone, Italy
Brasilia, Federal District, Brazil
Cascavel, Parana, Brazil
Sao Paulo, Brazil
Sao Paulo, Brazil
Salvador, Bahia, Brazil
Gyeonggi Do, Korea, Republic Of
Seoul, South Korea
Seville, Andalusia, Spain
Kuala Lumpur, Kuala Lumpur, Malaysia
Busan, South Korea
Busan, South Korea
Jeonju, Jeollabuk Do, South Korea
Daegu, South Korea
Yangsan, Gyeongsangnam Do, South Korea
Ulsan, South Korea
Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina
Heidelberg, Victoria, Australia
Salvador, Estado De Bahia, Brazil
Salvador, Estado De Bahia, Brazil
Salvador, Estado De Bahia, Brazil
Brasília, Federal District, Brazil
Cascavel, Brazil
Jaú, Brazil
São Paulo, Brazil
Santiago, Santiago Metropolitan, Chile
Gyeonggi Do, Gyeonggi Do, South Korea
Suwon, Gyeonggi Do, South Korea
Incheon, Namdong Gu, South Korea
Daegu, South Korea
Seoul, South Korea
Seoul, South Korea
Taoyuan District, Hunan Province, Taiwan
Changhua, Taiwan
Kaohsiung City, Taiwan
Mamak, Ankara, Turkey (Türkiye)
Ankara, Central Anatolia, Turkey (Türkiye)
Mezitli, Mersin, Turkey (Türkiye)
Tekirdağ, Suleymanpasa, Turkey (Türkiye)
Ankara, Turkey (Türkiye)
Istanbul, Turkey (Türkiye)
Izmir, Turkey (Türkiye)
Sakarya, Turkey (Türkiye)
Samsun, Turkey (Türkiye)
Zonguldak, Turkey (Türkiye)
Patients applied
Trial Officials
Clinical Trial Management
Study Director
Regeneron Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported