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)
The primary objective of the study is:
- To assess the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine
RP2D regimen(s) (defined as either a MTD regimen or a lower dose regimen) of
REGN5837 in combination with odronextamab in patients with relapsed or refractory
aggressive B-NHL.
The secondary objectives of the study are:
- To evaluate the pharmacokinetics (PK) of REGN5837 when given in combination with
odronextamab
- To evaluate the PK of odronextamab when given in combination with REGN5837
- To assess the immunogenicity of REGN5837 and odronextamab
- To assess the preliminary anti-tumor activity of REGN5837 in combination with
odronextamab in patients with relapsed or refractory aggressive B-NHL
The exploratory objectives of the study are:
- To evaluate the association between clinical efficacy and safety with biomarkers of
systemic immune activation (serum cytokine levels, T-cell counts and activation
markers)
- To evaluate the association between disease response and/or relapse and the change
from baseline in the count and phenotype of tumor-infiltrating T cells and tumor B cell
target antigen (CD20, CD22) expression
- To evaluate association of the molecular Minimal Residual Disease (MRD) status in
patients with a clinical CR with progression-free survival (PFS) and OS
- To assess other biomarkers (pharmacodynamic, predictive, and prognostic) potentially
related to REGN5837 in combination with odronextamab exposure, anti-tumor
activity, and safety
- To evaluate the relationships among pharmacodynamics, drug concentrations, and
clinical safety and efficacy measure
Odronextamab(REGN1979)
- Rutgers Cancer Institute of New Jersey
- Principal Investigator
- Matthew Matasar
- Principal Investigator
Key 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.
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. 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 Exclusion Criteria
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
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
5. Standard radiotherapy within 14 days of first administration of study drug.
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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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