Trial | NCT04082936  Report issue

Title

A Safety and Pharmacokinetic Study of IGM-2323 in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    260
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.
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).
Study Started
Sep 30
2019
Primary Completion
Sep 30
2024
Anticipated
Study Completion
Sep 30
2024
Anticipated
Last Update
Mar 28
2022

Drug IGM-2323

Subjects with r/r B-cell NHL will receive IGM-2323 via IV infusion.

Phase 1 (Dose Escalation) Experimental

Subjects will receive IGM-2323 via intravenous (IV) infusion weekly.

Phase 1 (Q3W) Experimental

Subjects will receive IGM-2323 via intravenous (IV) infusion every 3 weeks.

Phase 1 (Prior bi-specific) Experimental

Subjects treated with prior bi-specifics will receive IGM-2323 via IV infusion weekly.

Phase 2 (DLBCL) Experimental

DLBCL subjects will receive IGM-2323 via IV infusion at a dose and schedule to be determined after reviewing all available response and safety data.

Phase 2 (FL) Experimental

FL subjects will receive IGM-2323 via IV infusion at a dose and schedule to be determined after reviewing all available response and safety data.

Criteria 

Key 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.

Key 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
No Results Posted