Study of REGN1979 (anti-CD20 and anti- CD3) and REGN2810 in Patients with a Specific Type of Blood Cancer

Phase 1

• Conditions: B-cell malignancies; MedDRA version: 21.0Level: PTClassification code 10003903Term: B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10003917Term: B-cell type acute leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10026945Term: Mature B-cell type acute leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10067184Term: Burkitt's leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10003890Term: B precursor type acute leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10020267Term: Hodgkin's disease refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10020266Term: Hodgkin's disease recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10003902Term: B-cell lymphoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-001697-17-DE
• Lead Sponsor: Regeneron Pharmaceuticals, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-30
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

1-Principal Inclusion Criteria for B-NHL and HL Treatment Arms:

Hematologic malignancy defined by either:
a. NHL: Documented CD20+ B-cell malignancy, with active disease that is either refractory to or relapsed after most recent prior therapy, for whom no standard of care options exist, and for whom treatment with an anti-CD20 antibody may be appropriate:
i. B-NHL per WHO 2008 criteria (Campo 2011)
b. Documented HL, per WHO 2008 criteria (Campo 2011), with active disease not responsive to prior therapy or relapsed after prior therapy for whom no standard of care options exist (cemiplimab single agent therapy cohorts ONLY)

All patients must have at least one bi-dimensionally measurable lesion (=1.5 cm) documented by diagnostic imaging (CT, PET-CT, or MRI).

Eastern Cooperative Oncology Group (ECOG) performance status =1. Note: Individual cases of patients with ECOG 2 performance status may be discussed with the medical monitor for potential enrollment.

Age =18 years

Adequate bone marrow function documented by:
a. Platelet counts =75 x 109/L
b. Hb level =9 g/dL
c. ANC =1 x 109/L

Adequate hepatic function:
a. Total bilirubin =1.5 x ULN (=3 x ULN if liver involvement)
b. Transaminases =2.5 x ULN (=5 x ULN if liver involvement)
c. Alkaline phosphatase (ALP) =2.5 x ULN (=5 x ULN if liver involvement)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 86
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 86

Exclusion Criteria

1-Principal Exclusion Criteria for B-NHL and HL Treatment Arms

Primary central nervous system (CNS) lymphoma, or known or suspected CNS involvement by non-primary CNS NHL

History of or current relevant CNS pathology

Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for iAEs

History of treatment-related iAEs from immune-modulatory agents

Standard or investigational anti-neoplastic therapy (nonbiologic) within 5-times the half life or within 28 days, whichever is shorter, prior to first administration of study drug

Standard radiotherapy within 14 days of first administration of study drug

Treatment with alemtuzumab within 12 weeks prior to first administration of study drug(s)

Treatment with rituximab, immune-modulating agents or other investigational or commercial biologic agent less than 28 days prior to first administration of study drug(s).

Prior allogeneic stem cell transplantation

Prior treatment with an agent that blocks the PD-1/PD-L1 pathway, unless the patient demonstrated benefit (applicable only for patients in single-agent REGN2810 therapy)

Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; or other uncontrolled infection.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified