A Phase 1 Study to Investigate the Safety and Tolerability of REGN1979 in Patients With CD20+ B-Cell Malignancies



Status:Recruiting
Conditions:Blood Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:January 9, 2015
End Date:April 15, 2025
Contact:Clinical Trials Administrator
Email:clinicaltrials@regeneron.com

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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

This is an open-label, multi-center, dose escalation study of REGN1979 administered as an IV
(intravenous) infusion. This phase 1 study will investigate the safety and tolerability of
REGN1979 in patients with Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)


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:

2. NHL patients must have had prior treatment with an anti-CD20 antibody therapy

3. Must have at least one bi-dimensionally measurable lesion ≥1.5 cm) documented by CT
scan.

4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1

5. Life expectancy of at least 6 months

6. Adequate bone marrow function documented by:

1. Platelet counts ≥75 x 10^9/L

2. Hb level ≥9 g/dL

3. Absolute neutrophil count (ANC) ≥1 x 10^9/L

7. Adequate organ function

8. Willing and able to comply with clinic visits and study-related procedures

9. Provide signed informed consent

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

3. Allogeneic stem cell transplantation

4. Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis
B virus (HBV) or hepatitis C virus (HCV).

5. Known hypersensitivity to both allopurinol and rasburicase

6. History of hypersensitivity to any compound in the tetracycline antibiotics group

The information provided above is not intended to contain all considerations relevant to
potential participation in a clinical trial therefore not all inclusion/ exclusion criteria
are listed.
We found this trial at
9
sites
Tampa, Florida 33612
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Boston, MA
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New Brunswick, New Jersey 08903
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New Brunswick, NJ
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New York, New York 10021
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Orange, California 92868
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Orange, CA
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Rochester, Minnesota 55905
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Rochester, MN
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Stanford, CA
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Wurzburg,
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