Informations générales (source: ClinicalTrials.gov)
A Phase 1 Study to Assess Safety and Tolerability of REGN5837, an Anti-CD22 x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Odronextamab, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients With Aggressive B-Cell Non-Hodgkin Lymphomas (ATHENA-1)
Interventional
Phase 1
Regeneron Pharmaceuticals (Voir sur ClinicalTrials)
avril 2023
mai 2029
14 septembre 2025
The study is researching an experimental drug called REGN5837 in combination with another
experimental drug, odronextamab (called "study drugs").
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.
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 the 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)
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Bordeaux - 33404 - Talence - Nouvelle Aquitaine - France | Contact (sur clinicalTrials) | ||||
| Hopital Saint Louis - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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, as described in the protocol.
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. 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
6. 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
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, as described in the protocol.
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. 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
6. 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
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, as described in the protocol
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, as described
in the protocol
5. Standard radiotherapy within 14 days of first administration of study drug, as
described in the protocol
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