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

IGM Biosciences

Status

Conditions: Relapsed/Refractory Non-Hodgkin Lymphomas

Treatments: Biological: IGM2323

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT06331832

2021-002339-44 (EudraCT Number)

2323-EAP

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.