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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

Tracking Information
First Submitted Date  ICMJE November 7, 2014
First Posted Date  ICMJE November 14, 2014
Last Update Posted Date November 7, 2019
Actual Study Start Date  ICMJE January 9, 2015
Estimated Primary Completion Date April 15, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2018)
Safety/overall frequency of adverse events [ Time Frame: Up to 24 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 11, 2014)
Safety/overall frequency of adverse events [ Time Frame: Day 1 to 1 year ]
Change History Complete list of historical versions of study NCT02290951 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
  • 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: Up to 24 months ]
  • Progression-free survival [ Time Frame: Up to 24 months ]
  • Overall Survival [ Time Frame: Up to 24 months ]
  • Minimal residual disease (MRD) for patients with CLL [ Time Frame: Up to 10 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2014)
  • Pharmacokinetics (Concentration of REGN1979) [ Time Frame: Day 1 to 1 year ]
    Peak plasma concentration (Cmax) of REGN1979
  • Immunogenicity (Anti-REGN1979 antibodies) [ Time Frame: Day 1 to 1 year ]
    Anti-REGN1979 antibodies
  • Overall response rate (ORR) [ Time Frame: Day 1 to 1 year ]
  • Progression-free survival [ Time Frame: Day 1 to 1 year ]
  • Overall Survival [ Time Frame: Day 1 to 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Study to Investigate the Safety and Tolerability of REGN1979 in Patients With CD20+ B-Cell Malignancies
Official Title  ICMJE 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
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-Hodgkin's Lymphoma
  • Chronic Lymphocytic Leukemia
Intervention  ICMJE Drug: REGN1979 multiple dose levels
Study Arms  ICMJE
  • Experimental: Experimental cohorts N
    Experimental cohorts N (participants with CD20+NHL) will receive multiple dose levels of REGN1979
    Intervention: Drug: REGN1979 multiple dose levels
  • Experimental: Experimental cohorts C
    Experimental cohorts C (participants with CLL) will receive multiple dose levels of REGN1979
    Intervention: Drug: REGN1979 multiple dose levels
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 5, 2019)
246
Original Estimated Enrollment  ICMJE
 (submitted: November 11, 2014)
150
Estimated Study Completion Date  ICMJE April 15, 2025
Estimated Primary Completion Date April 15, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02290951
Other Study ID Numbers  ICMJE R1979-HM-1333
2015-004491-30 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP