This is a Phase 1/2 study of imvotamab in adult subjects with relapsed or refractory
B-cell Non-Hodgkin Lymphoma. This study will consist of a dose-escalation stage, a
combination stage, and a randomized dose-expansion stage where subjects will be enrolled
into indication-specific expansion cohorts. imvotamab will be administered intravenously
(IV).
Additional CD20-positive NHL histologies (e.g. MZL and MCL), may be allowed with Medical
Monitor approval during the Dose-Escalation Phase of the study.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04082936.
Imvotamab is an engineered bispecific IgM antibody for the treatment of patients with
CD20-positive cancers. It contains ten high affinity binding domains for CD20, and one
binding domain for CD3. Imvotamab is able to eliminate CD20-positive lymphoma cells by
engaging T-cells and lymphoma cells, leading to T-cell dependent cellular cytotoxicity.
Additionally, imvotamab is also able to eliminate lymphoma cells by recruiting complement
to the surface of lymphoma cells, leading to complement dependent cytotoxicity.
In our preclinical studies, we observed activity against rituximab resistant cells
carrying low levels of CD20. We have also observed much lower cytokine release with
imvotamab relative to comparable IgG format bispecific T-cell engaging antibodies, which
is expected to result in reduced risk of the serious adverse effects from cytokine
release syndrome (CRS).
For the combination stage, imvotamab will be combined with loncastuximab tesirine, a
CD19-targeting antibody drug conjugate.
Lead OrganizationIGM Biosciences, Inc.
