An Open-label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti-CD20 X Anti-CD3 Bispecific Antibody, in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Overview

About this study

The primary objective of this study is to assess the anti-tumor activity of single agent REGN1979 as measured by the objective response rate (ORR) according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) non-Hodgkin lymphoma (B-NHL) subgroups.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age 18 years or greater.

For the FL grade 1-3a cohort only:

  • Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible for this cohort but may be included in the “Other B-NHL” cohort. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification (Swerdlow, 2017).

Disease-specific cohorts:

Patients should, in the judgment of the investigator, require systemic therapy for lymphoma at the time of study enrollment and should be deemed not appropriate for any other approved therapy with established benefit for that indication.

  • FL grade 1-3a cohort: patients with FL grade 1-3a that has relapsed after or is refractory to at least 2 prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent; patients must have failed combination lenalidomide and rituximab treatment where approved or deemed not appropriate to receive this treatment according to the investigator.
  • DLBCL cohort: patients with DLBCL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent. Patients with de novo DLBCL or DLBCL that is transformed from a lower grade neoplasm (e.g., FL or CLL) may be enrolled. Patients with DLBCL transformation from prior CLL can only be enrolled in the absence of a leukemic CLL component. For patients with transformed DLBCL, prior systemic therapies administered for the lower grade neoplasm will not be considered among the prior lines of therapy for the purpose of determining eligibility

The following subtypes based on the WHO classification are eligible:

  • DLBCL not otherwise specified (NOS)
    • Germinal center B-cell type
    • Activated B-cell type

 

  • MCL after BTK inhibitor therapy cohort: Patients with MCL who have relapsed after or are refractory to a BTK inhibitor. It is not necessary for BTK inhibitor therapy to comprise the most recent line of treatment. Patients may also be enrolled who have relapsed or have disease refractory to prior systemic therapy, or who have demonstrated intolerance to BTK inhibitor therapy and who have progressed after other systemic therapy.
  • MZL cohort: patients with MZL that has relapsed or is refractory to at least 2 prior lines of systemic therapy.

The following subtypes based on the WHO classification are eligible:

  • Extranodal MZL of mucosa-associated lymphoid tissue (MALT lymphoma)
  • Nodal marginal zone lymphoma
  • Splenic marginal zone lymphoma

 

  • Other B-NHL cohort: Patients with B-NHL other than FL grade 1-3a, DLBCL, MCL, or MZL) that has relapsed or is refractory to at least 2 prior lines of systemic therapy.

The following subtypes based on the WHO classification are eligible:

  • Primary mediastinal (thymic) large B-cell lymphoma
  • T-cell/histiocyte-rich large B-cell lymphoma
  • Epstein-Barr virus (EBV)+DLBCL, NOS
  • Burkitt lymphoma
  • Burkitt-like lymphoma with 11q aberration
  • High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements
  • High-grade B-cell lymphoma, NOS
  • B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma
  • Follicular lymphoma, grade 3b

Patients with Waldenstrom macroglobulinemia (WM, lymphoplasmacytic lymphoma) are excluded.

  • 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]).
  • Additional Inclusion Criteria may apply.

Exclusion Criteria:

  • 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).
  • 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.
  • History of allogeneic stem cell transplantation.
  • 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. Patients with a history seizure within 12 months prior to study enrollment are excluded.
  • Vaccination within 28 days prior to first study drug administration with a vector that has replicative potential.
  • Additional Exclusion Criteria may apply.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jose Villasboas Bisneto, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20467355

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