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Expanded Access of Imvotamab ...

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

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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

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Detailed Description

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Conditions

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Relapsed/Refractory Non-Hodgkin Lymphomas

Interventions

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IGM2323

Imvotamab is a recombinant monoclonal antibody of the IgM kappa isotype that targets the human CD20 antigen. Its component J-chain is fused to a single chain Fv antibody fragment which targets human CD3ε.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers