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

• ClinicalTrials.gov Identifier: NCT02290951
• Recruitment Status: Active, not recruiting
• First Posted: November 14, 2014
• Last Update Posted: November 7, 2019
• Sponsor: Regeneron Pharmaceuticals
• Information provided by (Responsible Party): Regeneron Pharmaceuticals

Tracking Information

• First Submitted Date: November 7, 2014
• First Posted Date: November 14, 2014
• Last Update Posted Date: November 7, 2019
• Actual Study Start Date: January 9, 2015
• Estimated Primary Completion Date: April 15, 2025 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 14, 2018): Safety/overall frequency of adverse events [ Time Frame: Up to 24 months ]
• Original Primary Outcome Measures (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 (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 (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: A Phase 1 Study to Investigate the Safety and Tolerability of REGN1979 in Patients With CD20+ B-Cell Malignancies
• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Non-Hodgkin's Lymphoma
• Chronic Lymphocytic Leukemia

• Intervention: Drug: REGN1979 multiple dose levels

Study Arms

• 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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: November 5, 2019): 246
• Original Estimated Enrollment (submitted: November 11, 2014): 150
• Estimated Study Completion Date: April 15, 2025
• Estimated Primary Completion Date: April 15, 2025 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany, United States

Administrative Information

• NCT Number: NCT02290951
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Regeneron Pharmaceuticals
• Study Sponsor: Regeneron Pharmaceuticals
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Trial Management; Regeneron Pharmaceuticals

• PRS Account: Regeneron Pharmaceuticals
• Verification Date: October 2019