A Phase 1/2 Open-label, Multicenter Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of IGM-2323 in Subjects With Relapsed/Refractory Non-Hodgkin Lymphomas
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- STATUS
- Recruiting
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- End date
- Sep 24, 2024
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- participants needed
- 260
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- sponsor
- IGM Biosciences, Inc.
Summary
This is a Phase 1/2 study of IGM-2323 in adult subjects with relapsed or refractory B-cell Non-Hodgkin Lymphoma. This study will consist of a dose-escalation stage and a randomized dose-expansion stage where subjects will be enrolled into indication-specific expansion cohorts. IGM-2323 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.
Description
IGM-2323 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. IGM-2323 is able to eliminate CD20-positive lymphoma cells by engaging T-cells and lymphoma cells, leading to T-cell dependent cellular cytotoxicity. Additionally, IGM-2323 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 IGM-2323 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).
Details
| Condition | Non-Hodgkin Lymphoma, Follicular Lymphoma, DLBCL, Mantle Cell Lymphoma, Marginal Zone Lymphoma |
|---|---|
| Treatment | IGM-2323 |
| Clinical Study Identifier | NCT04082936 |
| Sponsor | IGM Biosciences, Inc. |
| Last Modified on | 24 October 2022 |
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