Trial record 3 of 46 for:    regeneron | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Regeneron Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02290951
First received: November 7, 2014
Last updated: March 18, 2015
Last verified: March 2015
  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 Intervention Phase
Non-Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Drug: REGN1979 multiple dose levels
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Safety/overall frequency of adverse events [ Time Frame: Day 1 to 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics (Concentration of REGN1979) [ Time Frame: Day 1 to 1 year ] [ Designated as safety issue: No ]
    Peak plasma concentration (Cmax) of REGN1979

  • Immunogenicity (Anti-REGN1979 antibodies) [ Time Frame: Day 1 to 1 year ] [ Designated as safety issue: No ]
    Anti-REGN1979 antibodies

  • Overall response rate (ORR) [ Time Frame: Day 1 to 1 year ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Day 1 to 1 year ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Day 1 to 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: November 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental cohorts N (participants with NHL)
Experimental cohorts N (participants with NHL) will receive multiple dose levels of REGN1979
Drug: REGN1979 multiple dose levels
Experimental: Experimental cohorts C (participants with CLL)
Experimental cohorts C (participants with CLL) will receive multiple dose levels of REGN1979
Drug: REGN1979 multiple dose levels

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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. 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 109/L
    2. Hb level ≥9 g/dL
    3. ANC ≥1 x 109/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. Prior therapy with blinatumomab.
  4. Allogeneic stem cell transplantation
  5. Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
  6. Known hypersensitivity to both allopurinol and rasburicase.

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
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, see Learn About Clinical Studies.

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

Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States
United States, New Jersey
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02290951     History of Changes
Other Study ID Numbers: R1979-HM-1333
Study First Received: November 7, 2014
Last Updated: March 18, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Leukemia
Leukemia, B-Cell
Lymphatic Diseases
Lymphoma
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 20, 2015