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.

Key Inclusion Criteria:

- 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 that has relapsed after or is refractory to at least 2 prior
lines of systemic therapy as defined in the protocol

- DLBCL cohort: Patients with DLBCL that has relapsed after or is refractory to at least
2 prior lines of systemic therapy as defined in the protocol

- MCL after BTK inhibitor therapy cohort: New enrollment is paused until further notice

- MZL cohort: New enrollment is paused until further notice

- Other B-NHL cohort: Patients with B-NHL other than FL grade 1-3a, DLBCL, MCL, or MZL
that has relapsed after or is refractory to at least 2 prior lines of systemic therapy
as defined in the protocol. New enrollment stopped for patients with Burkitt lymphoma
and Burkitt-like lymphoma.

- Patients should in the judgment of the investigator require systemic therapy for
lymphoma at the time of study enrollment

- Measurable disease on cross sectional imaging as defined in the protocol documented by
diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI)

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Adequate bone marrow, hepatic, and renal function as defined in the protocol

Key Exclusion Criteria:

- Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS
Non-Hodgkin Lymphoma (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

- 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

- History of neurodegenerative condition or CNS movement disorder. Patients with a
history of seizure within 12 months prior to study enrollment are excluded

- Another malignancy except B-NHL in the past 5 years, with the exception of
non-melanoma skin cancer that has undergone potentially curative therapy or in situ
cervical carcinoma, or any other tumor that has been deemed to be effectively treated
with definitive local control and with curative intent.

- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or
hepatitis C infection; cytomegalovirus (CMV) infection as noted by detectable levels
on a blood polymerase chain reaction (PCR) assay as defined in the protocol or other
uncontrolled infections

- Known hypersensitivity to both allopurinol and rasburicase

- Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Eligibility last updated 7/12/22. Questions regarding updates should be directed to the study team contact.

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.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20467355

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