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

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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.


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
We found this trial at
10
sites
Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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Baltimore, Maryland 21287
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Baltimore, MD
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Boston, Massachusetts 02215
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Boston, MA
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Cleveland, Ohio 44106
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Cleveland, OH
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Cologne,
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Grand Rapids, Michigan 49503
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Grand Rapids, MI
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Lebanon, New Hampshire 03756
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Lebanon, NH
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New York, New York 10065
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New York, NY
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San Antonio, Texas 78229
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San Antonio, TX
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Santa Monica, California 90404
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Santa Monica, CA
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