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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. Identifier: NCT04082936
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : May 19, 2021
Information provided by (Responsible Party):
IGM Biosciences, Inc.

Brief Summary:

This is a Phase 1 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 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

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Open-label, Multicenter Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of IGM-2323 in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: Part 1: Dose-Escalation Phase
Subjects will receive IGM-2323 via intravenous (IV) infusion on Days 1, 8, and 15, of 21-day cycles. Subjects will be treated with 4 cycles (3 weeks each). Subjects benefiting from therapy can receive up to 8 cycles or longer with good response. Dose escalation will be guided by the observed incidence of DLTs at each dose level.
Drug: IGM-2323
Subjects with r/r B-cell NHL will receive IGM-2323 via IV infusion.

Experimental: Part 2: Dose-Expansion Phase
Subjects will receive IGM-2323 via intravenous (IV) infusion at a RP2D 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.

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

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Baseline up to 1 year ]
    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 4 years ]
    measured from time of initial response until documented tumor progression

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

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).
  • 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.
  • Prior treatment with CD3 engaging bispecific antibodies.
  • 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

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 identifier (NCT number): NCT04082936

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Contact: Iris Sison 510-329-9857

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United States, Arizona
Honor Health Research Institute Recruiting
Phoenix, Arizona, United States, 85258
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
United States, Massachusetts
Dana Farber Cancer Institute (DFCI) Recruiting
Boston, Massachusetts, United States, 02215
United States, New York
NYU Recruiting
New York, New York, United States, 10016
MSKCC Recruiting
New York, New York, United States, 10065
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Washington
Fred Hutch Recruiting
Seattle, Washington, United States, 98109
Australia, Victoria
Monash Health Recruiting
Clayton, Victoria, Australia, 3168
St. Vincent's Hospital Melbourne Recruiting
Fitzroy, Victoria, Australia, 3065
Australia, Western Australia
Linear Clinical Resaerch Recruiting
Nedlands, Western Australia, Australia, 6009
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Sponsors and Collaborators
IGM Biosciences, Inc.
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Study Director: Wayne Godfrey, M.D. IGM Biosciences, Inc.
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Responsible Party: IGM Biosciences, Inc. Identifier: NCT04082936    
Other Study ID Numbers: IGM-2323-001
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: May 19, 2021
Last Verified: May 2021

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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.:
Non-Hodgkin Lymphoma
Follicular Lymphoma
relapsed or refractory
Additional relevant MeSH terms:
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Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, Mantle-Cell
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Immunoglobulin M
Immunologic Factors
Physiological Effects of Drugs