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Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies

Trial Status: Active

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 B-NHL and CLL. The dose escalation phase for B-NHL and the CLL study are closed at the time of protocol amendment 17. In part B, odronextamab is studied as a subcutaneous (SC) administration with a dose finding and a dose expansion phase for B-NHL.

Inclusion Criteria

  • 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.
  • 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

Exclusion Criteria

  • 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) or, 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

California

Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: ACTIVE
Palo Alto
Stanford Cancer Institute Palo Alto
Status: ACTIVE

Florida

Tampa
Moffitt Cancer Center
Status: COMPLETED

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: ACTIVE
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE
Massachusetts General Hospital Cancer Center
Status: ACTIVE

Minnesota

Rochester
Mayo Clinic in Rochester
Status: ACTIVE

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: ACTIVE

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Regeneron Pharmaceuticals, Inc.

  • Primary ID R1979-HM-1333
  • Secondary IDs NCI-2015-00136, 2015-004491-30
  • Clinicaltrials.gov ID NCT02290951