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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04082936
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : December 29, 2022
Sponsor:
Information provided by (Responsible Party):
IGM Biosciences, Inc.

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Non-Hodgkin Lymphoma Follicular Lymphoma DLBCL Mantle Cell Lymphoma Marginal Zone Lymphoma Drug: IGM-2323 Phase 1 Phase 2

Detailed 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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 1 (Dose Escalation)
Subjects will receive IGM-2323 via intravenous (IV) infusion weekly.
 Drug: IGM-2323
Subjects with r/r B-cell NHL will receive IGM-2323 via IV infusion.
Experimental: Phase 1 (Q3W)
Subjects will receive IGM-2323 via intravenous (IV) infusion every 3 weeks.
 Drug: IGM-2323
Subjects with r/r B-cell NHL will receive IGM-2323 via IV infusion.
Experimental: Phase 1 (Prior bi-specific)
Subjects treated with prior bi-specifics will receive IGM-2323 via IV infusion weekly.
 Drug: IGM-2323
Subjects with r/r B-cell NHL will receive IGM-2323 via IV infusion.
Experimental: Phase 2 (DLBCL)
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.
 Drug: IGM-2323
Subjects with r/r B-cell NHL will receive IGM-2323 via IV infusion.
Experimental: Phase 2 (FL)
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.
 Drug: IGM-2323
Subjects with r/r B-cell NHL will receive IGM-2323 via IV infusion.


Outcome Measures
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Primary Outcome Measures :
  1. Overall Frequency of Adverse Events [ Time Frame: Baseline through approximately 30 days after last study treatment ]
    Percentage of Adverse Events

  2. Overall Response Rate (ORR) [ Time Frame: Baseline up to 5 years ]
    Percentage of measurable disease in subjects who have achieved either complete response (CR) or partial response (PR)


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Baseline up to 5 years ]
    Percentage of measurable disease in subjects who have achieved either complete response (CR) or partial response (PR)

  2. Duration of Response (DOR) [ Time Frame: Baseline up to 5 years ]
    measured from time of initial response until documented tumor progression


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082936


Contacts
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Contact: Ibrahim Qazi 814-659-9591 clinicaltrials@IGMbio.com

Locations
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Sponsors and Collaborators
IGM Biosciences, Inc.
Investigators
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Study Director: Ibrahim Qazi IGM Biosciences, Inc.
More Information
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Responsible Party: IGM Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT04082936    
Other Study ID Numbers: IGM-2323-001
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: December 29, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IGM Biosciences, Inc.:
Lymphoma
Non-Hodgkin Lymphoma
DLBCL
Follicular Lymphoma
relapsed or refractory
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, Mantle-Cell
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
 Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell