A Study to Assess the Anti-Tumor Activity and Safety of REGN1979 in patients with Follicular Lymphoma that has been previously treated

Phase 1

• Conditions: Follicular lymphoma; MedDRA version: 22.0Level: PTClassification code 10029547Term: Non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002139-41-ES
• Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-26
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Principal inclusion in the study are:
1. Age 18 years or greater
2. Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification (Swerdlow, 2017).
3. Must have received at least 2 prior lines of therapy, including an anti-CD20 antibody and an alkylating agent.
4. Measurable disease on cross sectional imaging (defined as at least 1 bi dimensionally measurable nodal lesion of =1.5 cm in the greatest transverse diameter (GTD) regardless of the short axis diameter) documented by diagnostic imaging (computed tomography [CT], or magnetic resonance imaging [MRI]).
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or1.
6. Adequate bone marrow function as documented by:
a. Platelet count =50 x 109/L. A patient may not have received platelet transfusion within 7 days prior to first dose of REGN1979 in order to meet the platelet eligibility criterion.
b. Hemoglobin =9.0 g/dL
c. Absolute neutrophil count (ANC) =1.0 x 109/L. A patient may not have received granulocyte colony stimulating factor within 2 days prior to first dose of REGN1979 in order to meet the ANC eligibility criterion.
7. Adequate hepatic function

Refer to protocol for the full list of inclusion criteria of the trial
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 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 68

Exclusion Criteria

Principal exclusion criteria are:
1. Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL (suspected CNS lymphoma should be evaluated by lumbar puncture, as appropriate, in addition to the mandatory head CT or MRI).
2. Treatment with any systemic anti lymphoma therapy within 5 half-lives or within 28 days prior to first administration of study drug, whichever is shorter.
3. History of allogeneic stem cell transplantation
4. Prior treatment with any chimeric antigen receptor T-cell (CAR-T) therapy
5. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug
6. History of neurodegenerative condition or CNS movement disorder
7. Vaccination within 28 days prior to first study drug administration with a vector that has replicative potential

Refer to protocol for the full list of exclusion criteria of the trial

Study & Design

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