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

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

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT06331832
Enrollment
Unknown
Registered
2024-03-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed/Refractory Non-Hodgkin Lymphomas

Brief summary

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

Interventions

BIOLOGICALIGM2323

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.

Sponsors

IGM Biosciences, Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Countries

Australia, South Korea, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026