Clinical Trial - NCT02290951

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

Recruiting

Sponsor: Regeneron Pharmaceuticals

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02290951

Protocol Info

Short Description: Phase 1 of REGN1979 for CD20+ B-Cell Malignancies
Long Description: 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
MGH Status: Open
Sponsor: Regeneron Pharmaceuticals, Inc.
Disease Program: Lymphoma

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

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 Title Intervention Phase
Non-Hodgkin's Lymphoma Chronic Lymphocytic Leukemia REGN1979 multiple dose levels Phase 1
Study Type Interventional
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

Primary Outcome Measures

Safety/overall frequency of adverse events [Time Frame: Up to 24 months] [Designated as safety issue: ]


Secondary Outcome Measures

Pharmacokinetics (Concentration of REGN1979) [Time Frame: Up to 10 months] [Designated as safety issue: ]

Immunogenicity (Anti-REGN1979 antibodies) [Time Frame: Up to 15 months] [Designated as safety issue: ]

Overall response rate (ORR) [Time Frame: Up to 24 months] [Designated as safety issue: ]

Progression-free survival [Time Frame: Up to 24 months] [Designated as safety issue: ]

Overall Survival [Time Frame: Up to 24 months] [Designated as safety issue: ]

Minimal residual disease (MRD) for patients with CLL [Time Frame: Up to 10 months] [Designated as safety issue: ]

Estimated Enrollment: 198
Study Start Date: January 2015
Estimated Study Completion Date: April 2025
Estimated Primary Completion Date: April 2025
Arms Assigned Interventions

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

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02290951

Locations

  • 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

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02290951
Other Study ID Numbers: 2015-004491-30
Study First Received:
Last Updated:
Health Authority:

Additional relevant MeSH terms:

Lymphoma, Non-Hodgkin

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Antibodies, Bispecific

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on July 18, 2019