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

IGM Biosciences, Inc.3 个研究点分布在 3 个国家开始时间: 2024年3月26日最近更新: 2024年3月26日

适应症

试验速览

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

•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
•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.

•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.

发起方

申办方类型

Industry

责任方

Sponsor

Loading locations...