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R1979-HM-1333: An Open-label, Multi-center Phase I Study to Investigate the Safety and Tolerability of REGN1979, an anti-CD20 x anti-CD3 bispecific monoclonal antibody, in Patients with CD20+ B-cell Malignancies previously treated with CD20 directed antibody therapy.

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R1979-HM-1333: An Open-label, Multi-center Phase I Study to Investigate the Safety and Tolerability of REGN1979, an anti-CD20 x anti-CD3 bispecific monoclonal antibody, in Patients with CD20+ B-cell Malignancies previously treated with CD20 directed antibody therapy.

The primary objective of the study is to assess the safety, tolerability, and dose-limiting toxicities (DLTs) of REGN1979 administered intravenously (IV).

The secondary objectives of the study are:
* To characterize the pharmacokinetic (PK) profile of REGN1979
* To assess the immunogenicity of REGN1979
* To study the preliminary antitumor activity of REGN1979 administered to patients with CD20+ B-cell malignancies (non-Hodgkin's lymphoma [NHL] and chronic lymphocytic leukemia [CLL]) previously treated with anti-CD20 antibody therapy.
o Minimal residual disease (MRD) assessments in patients with CLL

The exploratory objectives of the study are:
* To evaluate biomarkers that may correlate with mechanism of action, observed toxicity, and potential anti-tumor activity including, but not limited, to:
o Cytokine profiling
o Peripheral blood B-cell and T-cell subsets and immune phenotyping
o Changes in gene expression in peripheral blood

Protocol Number: 011411
Phase: Phase I
Applicable Disease Sites: Lymphoid Leukemia
Non-Hodgkin's Lymphoma
Drugs Involved: REGN1979
Principal Investigator: Rajat Bannerji
Research Nurse: Kathleen Kafka
For additional information about this trial, contact the Research Nurse listed above
Scope: National
Therapies Involved:
Participating Institutions: Rutgers Cancer Institute of New Jersey
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria. For additional information on this trial or other available clinical trials please contact the research nurse.

For further information about clinical trials, please contact us at 732-235-8675.

 

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