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

  • STATUS
    Recruiting
  • End date
    Sep 24, 2024
  • participants needed
    260
  • sponsor
    IGM Biosciences, Inc.
Updated on 24 October 2022
ct scan
stem cell transplantation
hodgkin's disease
measurable disease
follicular lymphoma
diffuse large b-cell lymphoma
b-cell lymphoma
mantle cell lymphoma
refractory b-cell non-hodgkin lymphoma
marginal zone lymphoma
large b-cell lymphoma
refractory follicular lymphoma
refractory non-hodgkin's lymphoma
non-hodgkin's lymphoma refractory

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 IdentifierNCT04082936
SponsorIGM Biosciences, Inc.
Last Modified on24 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

> 18 years of age: ECOG PS 0 or 1
Relapsed or Refractory Follicular Lymphoma (FL), and Diffuse Large B-cell Lymphoma (DLBCL), Mantle cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL) in dose escalation
Relapsed or refractory to at least two prior systemic treatment regimens (must include anti-CD20 chemo-immunotherapy regimen). FL/MZL may be enrolled with a least 2 prior systemic regimens which must include an anti-CD20, without the need for a prior chemotherapy regimen)
At least one bi-dimensionally measurable lesion (>1.5cm in it's longest dimension by computerized tomography (CT scan)
Good organ function
Not eligible for autologous stem cell transplant (DLBCL subjects), due to chemoresistant disease, medically unfit (organ function), or unwilling

Exclusion Criteria

Prior allogeneic transplant
ASCT within 100 days prior to the first IGM-2323 administration
Lack of response to prior treatment with CAR-T therapy, subjects with less than 3 months from prior CAR-T therapy to first dose of IGM-2323, and prior CAR-T therapy only allowed with Medical Monitor approval
Concurrent serious co-morbidities that could limit patients full participation and compliance
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