Study of REGN2810 and REGN1979 in Patients With Lymphoma
Status: | Recruiting |
---|---|
Conditions: | Blood Cancer, Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/13/2018 |
Start Date: | January 11, 2016 |
End Date: | November 6, 2020 |
Contact: | Clinical Trials Administrator |
Email: | clinicaltrials@regeneron.com |
A Phase 1 Study to Assess Safety and Tolerability of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, and REGN2810, an Anti-Programmed Death-1 Monoclonal Antibody, in Patients With B-Cell Malignancies
This is an open-label, multicenter, dose escalation study of REGN2810 and REGN1979 in
patients with lymphoma. The study treatment period will be from 6 to 12 months, depending on
how an individual patient responds to treatment. The follow-up period will be 6 months for
all patients.
patients with lymphoma. The study treatment period will be from 6 to 12 months, depending on
how an individual patient responds to treatment. The follow-up period will be 6 months for
all patients.
Key Inclusion Criteria [(Non-Hodgkin Lymphoma (NHL) and Hodgkin Lymphoma (HL)]:
1. Have documented CD20+ B-cell NHL or documented HL, with active disease that is either
not responsive to or relapsed after prior therapy, for whom no standard of care
options exists.
2. Must have at least 1 bi-dimensionally measurable lesion (≥1.5 cm) documented by
diagnostic imaging (CT, PET-CT or MRI).
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
4. Life expectancy of at least 6 months
5. Adequate bone marrow function
6. Adequate organ function
7. Willing and able to comply with clinic visits and study-related procedures
8. Provide signed informed consent
Key Exclusion Criteria (NHL and HL):
1. Primary central nervous system (CNS) lymphoma, or known or suspected CNS involvement
by nonprimary CNS NHL
2. History of or current relevant CNS pathology
3. Ongoing or recent (within 2 years) evidence of significant autoimmune disease that
required treatment with systemic immunosuppressive treatments, which may suggest risk
for iAEs
4. Prior allogeneic stem cell transplantation
5. Prior treatment with an agent that blocks the programmed death-1/ programmed
death-ligand 1 (PD-1/PD-L1 pathway), unless benefit was demonstrated
6. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or
hepatitis C infection or other uncontrolled infection
7. History of hypersensitivity to any compound in the tetracycline antibiotics group
8. Known hypersensitivity to both allopurinol and rasburicase
9. Pregnant or breastfeeding women
10. Continued sexual activity in men or women of childbearing potential who are unwilling
to practice adequate contraception during the study
11. Prior treatment with idelalisib
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