Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies
Trial Status: Active
This is an open-label, multi-center, dose escalation study of odronextamab administered as an IV (intravenous) infusion. This phase 1 study will investigate the safety and tolerability of odronextamab in patients with B-cell Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)
- 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.
- Patients with NHL must have had prior treatment with an anti-CD20 antibody therapy. Patients with CLL are not required to have received prior treatment with an anti-CD20 antibody therapy, provided the patient has failed either a BTK inhibitor or PI3K inhibitor and the treating physician deems it appropriate for the patient to be entered into a phase 1 trial.
- For inclusion in the FL grade 1-3a expansion cohort, patients must have received at least 2 prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent.
- 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.
- Must have at least one bi-dimensionally measurable lesion ≥1.5 cm on the longest diameter documented by CT or MRI scan.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Life expectancy of at least 6 months
- Adequate bone marrow function documented by:
- Platelet counts ≥75 x 10^9/L
- Hb level ≥9 g/dL
- Absolute neutrophil count (ANC) ≥1 x 10^9/L
- Adequate organ function documented by:
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 X ULN
- Total bilirubin ≤1.5 X ULN
- Calculated creatinine clearance by Cockcroft-Gault ≥50 mL/min (patients with borderline creatinine clearance by Cockcroft-Gault may be considered for enrollment if a measured creatinine clearance (based on 24-hour urine or other reliable method) is ≥50 mL/min)
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
- Primary central nervous system (CNS) lymphoma or known or suspected CNS involvement by non-primary CNS NHL
- History of or current relevant CNS pathology
- Allogeneic stem cell transplantation
- Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients with hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus 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.
- Known hypersensitivity to both allopurinol and rasburicase
- History of hypersensitivity to any compound in the tetracycline antibiotics group
UC Irvine Health / Chao Family Comprehensive Cancer Center
Stanford Cancer Institute Palo Alto
Moffitt Cancer Center
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Massachusetts General Hospital Cancer Center
Mayo Clinic in Rochester
Rutgers Cancer Institute of New Jersey
Memorial Sloan Kettering Cancer Center
Trial Phase Phase I
Trial Type Treatment
Regeneron Pharmaceuticals, Inc.
- Primary ID R1979-HM-1333
- Secondary IDs NCI-2015-00136, 2015-004491-30
- Clinicaltrials.gov ID NCT02290951