EUCTR2015-001697-17-ES
Active, not recruiting
Phase 1
A Phase 1 Study to Assess Safety and Tolerability of REGN1979, an anti-CD20 x anti- CD3 bispecific monoclonal antibody, and REGN2810, an anti-programmed death-1 (PD-1) monoclonal antibody, in Patients with B-cell Malignancies
Regeneron Pharmaceuticals, Inc0 sites318 target enrollmentOctober 15, 2015
ConditionsB-cell malignanciesMedDRA version: 18.1Level: PTClassification code 10003903Term: B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10003917Term: B-cell type acute leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10026945Term: Mature B-cell type acute leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10067184Term: Burkitt's leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10020267Term: Hodgkin's disease refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10003890Term: B precursor type acute leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10020266Term: Hodgkin's disease recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: 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]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- B-cell malignancies
- Sponsor
- Regeneron Pharmaceuticals, Inc
- Enrollment
- 318
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Principal Inclusion Criteria for B\-cell 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, or for whom alternative available options are not considered appropriate and for whom treatment with an anti\-CD20 antibody may be appropriate:
- •i. B\-NHL confirmed by the Lugano Classification, 2014
- •b. Documented Hodgkin?s lymphoma (HL), with active disease not responsive to prior therapy or relapsed after prior therapy for whom no standard of care options exist or for whom alternative available options are not considered appropriate. (REGN2810 single\-agent therapy cohorts ONLY)
- •All patients must have at least one bi\-dimensionally measurable lesion (?1\.5 cm) documented by diagnostic imaging (CT or MRI).
- •Age ?18 years
- •Adequate bone marrow function documented by:
- •a. Platelet counts ?75 x 109/L
- •b. Hb level ?9 g/dL
Exclusion Criteria
- •Principal Exclusion Criteria for B\-cell 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
- •Standard anti\-lymphoma chemotherapy (non\-biologic) or radiotherapy within 28 days prior to first administration of study drug(s)
- •Treatment with an investigational non\-biologic agent within 28 days prior to first administration of study drug(s).
- •Treatment with rituximab, alemtuzumab, immune\-modulating agents or other investigational or commercial biologic agent within 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).
- •Principal Exclusion Criteria for Acute Lymphoblastic Leukemia Treatment Arms
Outcomes
Primary Outcomes
Not specified
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