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

Inclusion Criteria

• •1. 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
• •2. 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
• •3. 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.
• •4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
• •5. Life expectancy of at least 6 months
• •6. Adequate bone marrow function as described in the protocol
• •7. Adequate organ function as described in the protocol
• •8. 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.
• •9. Willing and able to comply with clinic visits and study-related procedures
• •10. Provide signed informed consent or legally acceptable representative