Expanded Access of Imvotamab (IGM-2323) in Patients With R/R NHL

March 19, 2024 updated by: IGM Biosciences, Inc.

Treatment Guidelines for Expanded Access of Imvotamab (IGM-2323) in Patients With Relapsed/Refractory Non-Hodgkin Lymphomas From IGM-2323-001

Expanded Access of Imvotamab (IGM-2323) in Patients with Relapsed/Refractory Non-Hodgkin Lymphomas from IGM-2323-001 clinical trial.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Nedlands, Western Australia, Australia
        • Sir Charles Gairdner Hospital
  • Korea, Republic of
    • Gangnam-gu
      • Seoul, Gangnam-gu, Korea, Republic of
        • Samsung Medical Center
  • Spain
      • Madrid, Spain
        • START-Madrid Centro Integral Oncologico Clara Campal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  • Demonstrated clinical benefit (SD, PR, or CR) on clinical trial protocol IGM-2323-001
  • There is no adequate alternative treatment available for the patient.
  • Provided consent to continue treatment on expanded access program.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to the first dose.
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive measures.
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive.

Exclusion Criteria:

  • History of severe allergic or anaphylactic reactions to mAb (or recombinant antibody related fusion proteins).
  • Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of investigational product, or indicating patient would unlikely have potential benefit.
  • Pregnant, breastfeeding, or intending to become pregnant during the program or within 2 months after the final dose of imvotamab.
  • In the treating physician's judgement, the patient is unlikely to complete all procedures, including follow-up visits, or comply with the requirements for participation.
  • Vaccination with live virus vaccines during treatment and for 3 months following the last cycle of Imvotamab.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IGM Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2323-EAP
  • 2021-002339-44 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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