Study to Investigate the Safety and Tolerability of REGN1979 in Patients With CD20+ B-Cell Malignancies
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ClinicalTrials.gov Identifier: NCT02290951 |
Recruitment Status :
Active, not recruiting
First Posted : November 14, 2014
Last Update Posted : December 22, 2020
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Condition or disease | Intervention/treatment | Phase |
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Non-Hodgkin Lymphoma Chronic Lymphocytic Leukemia | Drug: REGN1979 multiple dose levels Drug: Rituximab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 480 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | January 9, 2015 |
Estimated Primary Completion Date : | April 17, 2025 |
Estimated Study Completion Date : | April 17, 2025 |

Arm | Intervention/treatment |
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Experimental: Experimental cohorts N
Experimental cohorts N (participants with CD20+NHL) will receive multiple dose levels of REGN1979 Rituximab lead-in cohort N will receive multiple dose regimens of REGN1979
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Drug: REGN1979 multiple dose levels
Administered by intravenous (IV) infusion Drug: Rituximab Rituximab will be administered prior to the first dose of REGN1979. |
Experimental: Experimental cohorts C
Experimental cohorts C (participants with CLL) will receive multiple dose levels of REGN1979
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Drug: REGN1979 multiple dose levels
Administered by intravenous (IV) infusion |
- Safety/overall frequency of adverse events [ Time Frame: Up to 24 months ]
- Antitumor activity as measured by the objective response rate(ORR) [ Time Frame: Through study completion, an average of 24 months ]
Expansion Cohorts:
- Diffuse large B-cell lymphoma (DLBCL) after failure of CAR-T therapy
- Aggressive lymphoma cohorts 1 and 2
- Follicular lymphoma (FL) grade 1-3a cohorts 1 and 2
- Rituximab lead-in
- Chronic lymphocytic leukemia (CLL)
- Pharmacokinetics (Concentration of REGN1979) [ Time Frame: Up to 10 months ]Peak plasma concentration (Cmax) of REGN1979
- Immunogenicity (Anti-REGN1979 antibodies) [ Time Frame: Up to 15 months ]Anti-REGN1979 antibodies
- Objective response rate (ORR) [ Time Frame: Through study completion, an average of 24 months ]For dose escalation portion and rituximab lead-in dose groups
- Progression-free survival [ Time Frame: Up to 48 months ]
- Overall Survival [ Time Frame: Up to 48 months ]
- Minimal residual disease (MRD) for patients with CLL [ Time Frame: Up to 24 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- 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.
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Patients with NHL must have had prior treatment with an anti-CD20 antibody therapy. Patients with CLL are not required to have received prior treatment with an anti-CD20 antibody therapy, provided the patient has failed either a BTK inhibitor or PI3K inhibitor and the treating physician deems it appropriate for the patient to be entered into a phase 1 trial.
- For inclusion in the FL grade 1-3a expansion cohort, patients must have received at least 2 prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent.
- 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.
- Must have at least one bi-dimensionally measurable lesion ≥1.5 cm) documented by CT or MRI scan.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Life expectancy of at least 6 months
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Adequate bone marrow function documented by:
- Platelet counts ≥75 x 10^9/L
- Hb level ≥9 g/dL
- Absolute neutrophil count (ANC) ≥1 x 10^9/L
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Adequate organ function documented by:
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 X ULN
- Total bilirubin ≤1.5 X ULN
- Calculated creatinine clearance by Cockcroft-Gault ≥50 mL/min (patients with borderline creatinine clearance by Cockcroft-Gault may be considered for enrollment if a measured creatinine clearance (based on 24-hour urine or other reliable method) is ≥50 mL/min)
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Key Exclusion Criteria:
- Primary central nervous system (CNS) lymphoma or known or suspected CNS involvement by non-primary CNS NHL
- History of or current relevant CNS pathology
- Allogeneic stem cell transplantation
- Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients with hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus 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.
- Known hypersensitivity to both allopurinol and rasburicase
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290951
United States, California | |
University of California, Irvine | |
Orange, California, United States, 92868 | |
Stanford University | |
Stanford, California, United States, 94305 | |
United States, Florida | |
Moffitt Cancer Center | |
Tampa, Florida, United States, 33612 | |
United States, Massachusetts | |
Dana Farber Cancer Institute (Massachusetts General Hospital and Beth Israel) | |
Boston, Massachusetts, United States, 02215 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, New Jersey | |
Rutgers Cancer Institute of New Jersey | |
New Brunswick, New Jersey, United States, 08901 | |
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 | |
Weill Cornell Medical College | |
New York, New York, United States, 10065 | |
Germany | |
Universitatsklinikum Wurzburg | |
Wurzburg, Germany |
Study Director: | Clinical Trial Management | Regeneron Pharmaceuticals |
Responsible Party: | Regeneron Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT02290951 |
Other Study ID Numbers: |
R1979-HM-1333 2015-004491-30 ( EudraCT Number ) |
First Posted: | November 14, 2014 Key Record Dates |
Last Update Posted: | December 22, 2020 |
Last Verified: | February 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Diffuse large B-cell lymphoma (DLBCL) Follicular lymphoma (FL) Aggressive lymphoma |
Lymphoma Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, Lymphoid |
Leukemia Leukemia, B-Cell Rituximab Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |