A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previously Treated With Other Cancer Therapies
Launched by REGENERON PHARMACEUTICALS · Mar 20, 2019
Trial Information
Current as of July 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called odronextamab for adults with B-cell non-Hodgkin lymphoma (B-NHL) who have already tried other cancer therapies. The main goal is to see how effective odronextamab is at killing cancer cells and to learn more about its safety. Researchers are interested in understanding how the drug works in the body, any side effects participants might experience, and how much of the drug is found in the bloodstream.
To participate in this study, patients generally need to be aged between 65 and 74 and have a specific type of B-NHL that has not responded to at least two prior treatments. They should have measurable disease as shown by imaging tests like CT or MRI scans. However, some people may not be eligible, such as those with certain types of lymphoma affecting the brain or those who have had recent treatments that could interfere with the study. Participants can expect regular check-ups to monitor their health and any side effects while taking odronextamab. This trial is currently recruiting, and it offers a chance to contribute to important research that could help improve treatment for B-NHL in the future.
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • 1. For the FL grade 1-3a cohort only: Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible for this cohort but may be included in the "other B-NHL" cohort. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification (Swerdlow, 2017)
- 2. Disease-specific cohorts:
- • Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment
- • FL grade 1-3a cohort: Patients with FL grade 1-3a that has relapsed after or is refractory to at least 2 prior lines of systemic therapy, as defined in the protocol
- • DLBCL cohort: Patients with DLBCL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol
- • MCL after BTK inhibitor therapy cohort: Patients with MCL who have relapsed or refractory disease to at least one prior line of systemic therapy and had prior treatment with a Bruton's tyrosine kinase (BTK) inhibitor
- • MZL cohort: Patients with MZL that have relapsed or is refractory to at least 2 prior lines of systemic therapy
- • Other B-NHL cohort: Patients with B-NHL other than FL grade 1-3a, DLBCL, MCL, or MZL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol. New enrollment stopped for patients with Burkitt lymphoma and Burkitt-like lymphoma.
- • 3. Measurable disease on cross sectional imaging as defined in the protocol documented by diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI)
- • 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- • 5. Adequate bone marrow, hepatic, and renal function as defined in the protocol
- Key Exclusion Criteria:
- • 1. Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS Non-Hodgkin Lymphoma (NHL) (suspected CNS lymphoma should be evaluated by lumbar puncture, as appropriate, in addition to the mandatory head CT or MRI)
- • 2. Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 28 days prior to first administration of study drug, whichever is shorter
- • 3. History of allogeneic stem cell transplantation, up to 12 months prior to first administration of study drug. The presence of acute or chronic graft-versus host disease (GVHD) will also be an exclusion
- • 4. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug
- • 5. History of neurodegenerative condition or CNS movement disorder. Patients with a history of seizure within 12 months prior to study enrollment are excluded
- • 6. Another malignancy except B-NHL in the past 5 years, with the exception of non-melanoma skin cancer that has undergone potentially curative therapy or in situ cervical carcinoma, or any other tumor that has been deemed to be effectively treated with definitive local control and with curative intent
- • 7. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; cytomegalovirus (CMV) infection as noted by detectable levels on a blood polymerase chain reaction (PCR) assay as defined in the protocol or other uncontrolled infections
- • 8. Known hypersensitivity to both allopurinol and rasburicase
- • 9. Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy
- • 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
Ann Arbor, Michigan, United States
Cleveland, Ohio, United States
Iowa City, Iowa, United States
Boston, Massachusetts, United States
Caen, , France
Edinburgh, Scotland, United Kingdom
Madrid, , Spain
Chicago, Illinois, United States
Perth, Western Australia, Australia
Boston, Massachusetts, United States
Cleveland, Ohio, United States
Morristown, New Jersey, United States
Singapore, , Singapore
Geelong, Victoria, Australia
Winston Salem, North Carolina, United States
Salamanca, , Spain
Paris, , France
Saitama, , Japan
Nantes, , France
Palma De Mallorca, , Spain
Truro, , United Kingdom
Paris, , France
Iowa City, Iowa, United States
Cardiff, Wales, United Kingdom
Plymouth, , United Kingdom
Saint Louis, Missouri, United States
Perth, , Australia
Barcelona, , Spain
Rochester, Minnesota, United States
Stony Brook, New York, United States
Truro, Cornwall, United Kingdom
Barcelona, , Spain
Cardiff, , United Kingdom
Beijing, , China
Edinburgh, , United Kingdom
Louisville, Kentucky, United States
London, , United Kingdom
Pierre Bénite, , France
Firenze, , Italy
New York, New York, United States
Beijing, Beijing, China
Taoyuan, , Taiwan
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Halifax, Nova Scotia, Canada
Barcelona, , Spain
Taipei, , Taiwan
Chiba, , Japan
Busan, , Korea, Republic Of
Barcelona, , Spain
Chengdu, Sichuan, China
Fort Sam Houston, Texas, United States
Shanghai, , China
Matsuyama, Ehime, Japan
Taichung City, , Taiwan
Sutton, Surrey, United Kingdom
Kobe, Hyogo, Japan
Taipei City, , Taiwan
Goyang Si, , Korea, Republic Of
Zhengzhou, Henan, China
Milano, , Italy
Murdoch, Western Australia, Australia
Warszawa, , Poland
Marbella, , Spain
Hackensack, New Jersey, United States
Marbella, Malaga, Spain
Seoul, , Korea, Republic Of
Sutton, , United Kingdom
Singapore, , Singapore
Seoul, , Korea, Republic Of
Hidaka, Saitama, Japan
Oklahoma City, Oklahoma, United States
San Giovanni Rotondo, , Italy
Beijing, , China
Wuhan, , China
Zhengzhou, Henan, China
Dallas, Texas, United States
Taipei City, , Taiwan
Hackensack, New Jersey, United States
Madrid, , Spain
Valencia, , Spain
Madrid, , Spain
Beijing, Beijing, China
Taipei City, , Taiwan
Chengdu, Sichuan, China
Stony Brook, New York, United States
New Taipei City, , Taiwan
Isehara Shi, Kanagawa, Japan
Seoul, , Korea, Republic Of
Créteil, , France
Fort Sam Houston, Texas, United States
Seoul, , Korea, Republic Of
Ulsan, , Korea, Republic Of
Hangzhou, Zhejiang, China
Ravenna, , Italy
Donostia, , Spain
Pessac, , France
Madrid, , Spain
Madrid, , Spain
Gdańsk, , Poland
Paris, , France
Singapore, , Singapore
Kashiwa Shi, Chiba Ken, Japan
San Giovanni Rotondo, Foggia, Italy
Tianjin, , China
Changchun, Jilin, China
New York, New York, United States
Isehara Shi, , Japan
Tianjin, , China
Wurzburg, , Germany
Xi'an, Shaanxi, China
Novara, , Italy
Madrid, , Spain
Chuo Ku, , Japan
Pessac, Aquitaine, France
Reggio Emilia, , Italy
Ann Arbor, Michigan, United States
East Albury, New South Wales, Australia
Venice, , Italy
Madrid, , Spain
Nagasaki, , Japan
Terni, , Italy
Boston, Massachusetts, United States
Rochester, Minnesota, United States
Saint Louis, Missouri, United States
East Albury, , Australia
East Melbourne, , Australia
Frankston, , Australia
Geelong, , Australia
Heidelberg, , Australia
Murdoch, , Australia
Tweed Heads, , Australia
Edmonton, Alberta, Canada
Beijing, Beijing, China
Guanngzhou City, Guangdong, China
Zhengzhou City, Henan, China
Qiaokou District, , China
Hangzhou, Zhejiang, China
Shangcheng District Hangzhou, Zhejiang, China
Beijing City Beijing, , China
Beijing City, Beijing, , China
Chaoyang District Changchun, , China
Gusu District Suzhou, , China
Hexi District Tianjin City, , China
Nangang District Harbin Heilongjiang, , China
Shapingba District Chongqing, , China
Tianjin City Tianjin, , China
Wuhan Hubei Province, , China
Xuhui District Shanghai, , China
Yanta District Xi'an Shanxi, , China
Lille, , France
Poitiers, , France
Chemnitz, , Germany
Halle, , Germany
Mutlangen, , Germany
Villingen Schwenningen, , Germany
Bologna, , Italy
Livorno, , Italy
Milano, , Italy
Perugia, , Italy
Reggio Emilia, , Italy
San Giovanni Rotondo, , Italy
Varese, , Italy
Nagoya, Aiti, Japan
Kobe, Hyōgo, Japan
Kyoto City, Kyoto, Japan
L'hospitalet De Llobregat, , Japan
Osaka City, , Japan
Tiba, , Japan
Yamagata City, , Japan
Daegu Si, , Korea, Republic Of
Gdynia, , Poland
Krakow, , Poland
Lodz, , Poland
Warszawa, , Poland
Warszawa, , Poland
Wrocław, , Poland
Singapore, , Singapore
Singapore, , Singapore
Barcelona, , Spain
Donostia, , Spain
L'hospitalet De Llobregat, , Spain
Palma, , Spain
Kaohsiung, , Taiwan
New Taipei City, , Taiwan
Tainan City, , Taiwan
Tainan, , Taiwan
Taipei City, , Taiwan
Hangzhou, Zhejiang, China
Dallas, Texas, United States
Wuhan, Hubei, China
Heilongjiang, , China
Nagoya, Aichi, Japan
Nagoya, Aiti, Japan
Fukuoka Shi, Hukuoka, Japan
Palma, Balearic Islands, Spain
Suzhou, Jiangsu, China
Wuhan, , China
Canton, , China
Chongqing, , China
Tianjin, , China
Xi'an, , China
Chemnitz, , Germany
Wuhan, Hubei, China
Kyoto City, Kyoto, Japan
Lodz, , Poland
Singapore, , Singapore
Pozuelo De Alarcon, Madrid, Spain
Krakow, Malopolskie, Poland
Heidelberg, Victoria, Australia
Kaohsiung City, , Taiwan
Varese, , Italy
Plymouth, Devon, United Kingdom
Madrid, , Spain
Pierre Benite, Lyon, France
Bologna, , Italy
Mutlangen, Gmund, Germany
Osaka City, Osaka, Japan
Chuo Ku, Tokyo, Japan
Winston Salem, North Carolina, United States
Tweed Heads, South Wales, Australia
East Melbourne, Victoria, Australia
Frankston, Victoria, Australia
Edmonton, Alberta, Canada
Halifax, Nova Scotia, Canada
Tianjin, Beijing, China
Chongqing, Chongqing, China
Guangzhou, Guangdong, China
Harbin, Heilongjiang, China
Suzhou, Jiangsu, China
Changchun, Jilin, China
Shanghai, Shanghai, China
Tianjin, Tianjin, China
Hangzhou, Zhejiang, China
Beijing, , China
Caen, Calvados, France
Créteil, Ile De France, France
Nantes, Loire, France
Lille, Nord, France
Poitiers, Vienne, France
Paris, , France
Villingen Schwenningen, Donaueschingen, Germany
Halle Saale, , Germany
Wurzburg, , Germany
Milano, Milan, Italy
Livorno, , Italy
Milano, , Italy
Perugia, , Italy
Terni, , Italy
Venice, , Italy
Chiba Shi, Tiba, Japan
Yamagata City, Yamagata Prefecture, Japan
Daegu Si, Daegu, Korea, Republic Of
Gyeonggi Do, Gyeonggi, Korea, Republic Of
Seoul, Gyeonggi, Korea, Republic Of
Seoul, Ulsan, Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Warszawa, Mazowieckie, Poland
Gdansk, Pomorskie, Poland
Gdynia, Pomorskie, Poland
Lodz, , Poland
Wroclaw, , Poland
Singapore, , Singapore
Barcelona, Catalonia, Spain
Palma, Illes Balears, Spain
Barcelona, , Spain
Taichung City, , Taiwan
Tainan City, , Taiwan
Tainan, , Taiwan
Taipei City, , Taiwan
Taoyuan, , Taiwan
Ulsan, Daegu, Korea, Republic Of
Patients applied
Trial Officials
Clinical Trial Management
Study Director
Regeneron Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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