Study of REGN1979 (anti-CD20 and anti- CD3) and REGN2810 (anti-PD-1) in Patients with a Specific Type of Blood Cancer

Phase 1

• Conditions: B-cell malignancies; MedDRA 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]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-15
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 318

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

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)

Inclusion Criteria for Acute Lymphoblastic Leukemia Study Arms

A patient must meet the following criteria to be eligible for inclusion in the study:

Documented relapsed or refractory CD20+ B-precursor ALL (defined as CD20 expression by flow cytometry on ?20% of leukemic lymphoblasts) after induction and one cycle of consolidation chemotherapy

a. Patients with Philadelphia chromosome positive (Ph+) ALL are required to have failed or be intolerant to second generation TKI

Age ?18 years

Central Nervous System (CNS) negative disease, confirmed by LP, within 28 days of starting study drug.

Adequate bone marrow function documented by:

a. Platelet counts ?10 x 109/L

b. Hb level ?7 g/dL

c. Absolute phagocyte count (APC) ?0.5 x 109/L (phagocytes: neutrophils, bands and monocytes)

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 214
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 106

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

History of or current relevant CNS pathology

Ongoing or recent (within 2 years) evidence of significant autoimmune disease (with the exception of GvHD) that required treatment with systemic immunosuppressive treatments

Standard anti-leukemia chemotherapy (non-biologic) or radiotherapy within 14 days prior to first administration of study drug(s)

Treatment with an investigational non-biologic agent within 14 days prior to first administration of study drug(s).

Treatment with rituximab, immune modulating agents or other investigational or commercial biologic agent within 14 days prior to first administration of study drug.

Treatment with alemtuzumab, within 12 weeks

Prior Allogeneic stem cell transplantation within 3 months of treatment

Study & Design

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