Status:
COMPLETED
Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Non-Hodgkin Lymphoma
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study has two parts with distinct study objectives and study design. In part A, odronextamab is studied as an intravenous (IV) administration with a dose escalation and a dose expansion phase for...
Eligibility Criteria
Inclusion
- Key
- Have documented CD20+ B-cell malignancy, with active disease not responsive to prior therapy, for whom no standard of care options exists, and for whom treatment with an anti-CD20 antibody may be appropriate:
- Part A (IV administration) B-NHL confirmed by National Cancer Institute (NCI) working group criteria
- Part B (SC administration): Confirmed diagnosis of B-NHL requiring therapy as defined by WHO classification 2017
- Patients with B-NHL must have had prior treatment with an anti-CD20 antibody therapy. Patients with CLL (Part A only) are not required to have received prior treatment with an anti-CD20 antibody therapy as defined in the protocol.
- For the inclusion in the disease-specific expansion cohort enrolling DLBCL patients after failure of CAR-T therapy, the patient must have recovered from the toxicities of the lymphodepletion therapy and CAR-T infusion.
- For inclusion in Part B, patients must have FL grade 1-3a or DLBCL (with or without prior CAR-T) per the criteria above, and:
- Patients with FL grade 1-3a and DLBCL must have received at least 2 prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent
- All patients must have at least one bi-dimensionally measurable lesion ≥1.5 cm) documented by CT or MRI scan, if CT scan is not feasible.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Life expectancy of at least 6 months
- Adequate bone marrow function as described in the protocol
- Adequate organ function as described in the protocol
- Willingness to undergo mandatory tumor biopsy pretreatment, if in the opinion of the investigator, the patient has an accessible lesion that can be biopsied without significant risk to the patient.
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent or legally acceptable representative
- Key
Exclusion
- Primary central nervous system (CNS) lymphoma or known or suspected CNS involvement by non-primary CNS NHL
- History of or current relevant CNS pathology such as
- Epilepsy, seizure, paresis, aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis, or
- Evidence for presence of inflammatory lesions and/or vasculitis on cerebral MRI
- Standard anti-lymphoma chemotherapy (non-biologic) or radiotherapy within 28 days prior to first administration of study drug
- Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or cytomegalovirus (CMV) infection \[(as noted by detectable levels on a blood polymerase chain reaction (PCR) assay)\].
- Patients with hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus deoxyribonucleic acid (DNA) that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted upon consultation with the physician managing the infection.
- Patients who show detectable levels of CMV at screening will need to be treated with appropriate antiviral therapy and demonstrate at least 2 undetectable levels of CMV by PCR assay (at least 7 days apart) before being re-considered for eligibility.
- Patients who have received a live vaccination within 28 days of first dose of study treatment
- Note: Other protocol Inclusion/Exclusion criteria apply
Key Trial Info
Start Date :
January 9 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02290951
Start Date
January 9 2015
End Date
August 21 2025
Last Update
October 10 2025
Active Locations (22)
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1
University of California, Irvine
Orange, California, United States, 92868
2
Stanford University
Stanford, California, United States, 94305
3
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114