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Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies
Trial ID: NCT02290951
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.
An Open-Label, Multi-Center Phase 1 Study to Investigate the Safety and Tolerability of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients With CD20+ B-Cell Malignancies Previously Treated With CD20-Directed Antibody Therapy (ELM-1)
Saul A. Rosenberg, MD, Professor of Lymphoma
Clinical Associate Professor, Medicine - Oncology
Hans-Christoph Becker, MD, FSABI, FSCCT
Clinical Professor, Radiology
Neel K. Gupta
Clinical Assistant Professor, Medicine - Oncology Clinical Assistant Professor, Medicine - Hematology
Key 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
Key Exclusion Criteria:
1. Primary central nervous system (CNS) lymphoma or known or suspected CNS involvement by
non-primary CNS NHL
2. 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
3. Standard anti-lymphoma chemotherapy (non-biologic) or radiotherapy within 28 days
prior to first administration of study drug
4. 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)].
1. 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.
2. 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
5. Patients who have received a live vaccination within 28 days of first dose of study
Note: Other protocol Inclusion/Exclusion criteria apply
drug: Odronextamab multiple dose levels
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