Odronextamab
- Generic Name
- Odronextamab
- Brand Names
- -
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1801338-64-6
- Unique Ingredient Identifier
- 8R5CM46UIO
- Background
Odronextamab is a hinge-stabilized, fully human immunoglobulin G4 (IgG4)-based CD20×CD3 bispecific antibody currently evaluated for the treatment of relapsed/refractory (R/R) B-Cell non-Hodgkin lymphoma (NHL). Preliminary studies have shown that in patients with R/R NHL, the use of odronextamab does not lead to the development of neurologic toxicity; however, it can lead to the development of cytokine release syndrome (CRS), a serious condition associated with the use of immunotherapy. In December 2020, the FDA placed a partial clinical hold and requested the drug developer, Regeneron Pharmaceuticals, to amend clinical protocols to reduce the incidence of CRS. The partial clinical hold was later lifted in May 2021.
A phase I clinical study (NCT02290951) showed that in heavily pre-treated patients with B-cell non-Hodgkin lymphoma, odronextamab elicited a durable response with a manageable safety profile.
- Associated Conditions
- -
- Associated Therapies
- -
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
- Conditions
- B-Cell Non-Hodgkin Lymphoma (B-NHL)
- Interventions
- First Posted Date
- 2024-01-30
- Last Posted Date
- 2025-01-07
- Lead Sponsor
- Regeneron Pharmaceuticals
- Target Recruit Count
- 216
- Registration Number
- NCT06230224
- Locations
- 🇦🇺
Liverpool Hospital, Liverpool, New South Wales, Australia
🇹🇷Zonguldak Bulent Ecevit Univesity, Zonguldak, Turkey
🇦🇺Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma
- Conditions
- Follicular Lymphoma (FL)
- Interventions
- Drug: OdronextamabDrug: CyclophosphamideDrug: RituximabDrug: DoxorubicinDrug: Prednisone/PrenisoloneDrug: Vincristine
- First Posted Date
- 2023-10-24
- Last Posted Date
- 2025-01-10
- Lead Sponsor
- Regeneron Pharmaceuticals
- Target Recruit Count
- 733
- Registration Number
- NCT06097364
- Locations
- 🇬🇧
The Hillingdon Hospitals NHS Foundation Trust, Uxbridge, London, United Kingdom
🇺🇸Investigative Clinical Research of Indiana, Noblesville, Indiana, United States
🇺🇸University of Kentucky, Lexington, Kentucky, United States
A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas
- Conditions
- B-cell Non-Hodgkins Lymphoma (B-NHL)
- Interventions
- Drug: OdronextamabDrug: REGN5837
- First Posted Date
- 2023-01-13
- Last Posted Date
- 2025-01-09
- Lead Sponsor
- Regeneron Pharmaceuticals
- Target Recruit Count
- 91
- Registration Number
- NCT05685173
- Locations
- 🇺🇸
City of Hope, Duarte, California, United States
🇺🇸Norton Cancer Institute, Louisville, Kentucky, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
Drug Development Updates
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