Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies
a study on Lymphoma Non-Hodgkin Lymphoma Chronic Lymphocytic Leukemia Leukemia
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at Orange, California and other locations
- Dates
- study startedcompletion around
Description
Summary
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.
Official Title
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)
Keywords
Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Diffuse large B-cell lymphoma (DLBCL), Follicular lymphoma (FL), Aggressive lymphoma, Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Odronextamab multiple dose levels
Eligibility
You can join if…
Open to people ages 18 years and up
- 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
You CAN'T join if...
- 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
- 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), 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
Note: Other protocol Inclusion/Exclusion criteria apply
Locations
- University of California, Irvine
Orange California 92868 United States - Stanford University
Stanford California 94305 United States
Details
- Status
- in progress, not accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Regeneron Pharmaceuticals
- ID
- NCT02290951
- Phase
- Phase 1 research study
- Study Type
- Interventional
- Participants
- About 200 people participating
- Last Updated