For Healthcare Professionals

A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma

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About the study

This is a Phase 1/2 study of imvotamab in adult subjects with relapsed or refractory B-cell Non-Hodgkin Lymphoma. This study will consist of a dose-escalation stage, a combination stage, and a randomized dose-expansion stage where subjects will be enrolled into indication-specific expansion cohorts. imvotamab 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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Key Inclusion Criteria:


  1. > 18 years of age: ECOG PS 0 or 1
  2. Relapsed or Refractory Follicular Lymphoma (FL), and Diffuse Large B-cell Lymphoma (DLBCL), Mantle cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL) in dose escalation
  3. 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)
  4. At least one bi-dimensionally measurable lesion (>1.5cm in it's longest dimension by computerized tomography (CT scan)
  5. Good organ function
  6. Not eligible for autologous stem cell transplant (DLBCL subjects), due to chemoresistant disease, medically unfit (organ function), or unwilling.

EXCLUSION CRITERIA

Key Exclusion Criteria:


  1. Prior allogeneic transplant
  2. ASCT within 100 days prior to the first imvotamab administration.
  3. 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 imvotamab, and prior CAR-T therapy only allowed with Medical Monitor approval.
  4. Concurrent serious co-morbidities that could limit patients full participation and compliance.
  5. Prior CD-targeting bispecific antibodies.
  6. Prior loncastuximab tesirine.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

DLBCL,Non-Hodgkin Lymphoma,Follicular Lymphoma,Mantle Cell Lymphoma,Marginal Zone Lymphoma

Age (in years)

18+

Phase

Phase 1/Phase 2

Participants needed

97

Est. Completion Date

Oct 31, 2024

Treatment type

Interventional


Sponsor

IGM Biosciences, Inc.

ClinicalTrials.gov identifier

NCT04082936

Study number

IGM-2323-001

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