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

Korábbi kezelés

• Standard anti-lymphoma chemotherapy (non-biologic) or radiotherapy within 28 days prior to first administration of study drug
• Patients who have received a live vaccination within 28 days of first dose of study treatment
  • Note: Other protocol Inclusion/Exclusion criteria apply

Más betegség

• 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

Laborértékek

• 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.

Egyéb

• Primary central nervous system (CNS) lymphoma or known or suspected CNS involvement by non-primary CNS NHL

• 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