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

2323-EAP

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

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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.

{'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}}

2024-03-26