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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02290951
Recruitment Status : Active, not recruiting
First Posted : November 14, 2014
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Chronic Lymphocytic Leukemia Drug: REGN1979 multiple dose levels Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 246 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 15, 2025
Estimated Study Completion Date : April 15, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental cohorts N
Experimental cohorts N (participants with CD20+NHL) will receive multiple dose levels of REGN1979
Drug: REGN1979 multiple dose levels
Experimental: Experimental cohorts C
Experimental cohorts C (participants with CLL) will receive multiple dose levels of REGN1979
Drug: REGN1979 multiple dose levels



Primary Outcome Measures :
  1. Safety/overall frequency of adverse events [ Time Frame: Up to 24 months ]

Secondary Outcome Measures :
  1. Pharmacokinetics (Concentration of REGN1979) [ Time Frame: Up to 10 months ]
    Peak plasma concentration (Cmax) of REGN1979

  2. Immunogenicity (Anti-REGN1979 antibodies) [ Time Frame: Up to 15 months ]
    Anti-REGN1979 antibodies

  3. Objective response rate (ORR) [ Time Frame: Up to 24 months ]
  4. Progression-free survival [ Time Frame: Up to 24 months ]
  5. Overall Survival [ Time Frame: Up to 24 months ]
  6. Minimal residual disease (MRD) for patients with CLL [ Time Frame: Up to 10 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. Patients with NHL must have had prior treatment with an anti-CD20 antibody therapy as defined in the protocol
  3. Must have at least one bi-dimensionally measurable lesion ≥1.5 cm) documented by CT or MRI 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) as defined in the protocol
  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.


Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02290951     History of Changes
Other Study ID Numbers: R1979-HM-1333
2015-004491-30 ( EudraCT Number )
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Leukemia
Leukemia, B-Cell