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 |
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)
(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
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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