Expanded Access of Imvotamab (IGM-2323) in Patients With R/R NHL
- Conditions
- Relapsed/Refractory Non-Hodgkin Lymphomas
- Registration Number
- NCT06331832
- Lead Sponsor
- IGM Biosciences, Inc.
- Brief Summary
Expanded Access of Imvotamab (IGM-2323) in Patients with Relapsed/Refractory Non-Hodgkin Lymphomas from IGM-2323-001 clinical trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Samsung Medical Center
🇰🇷Seoul, Gangnam-gu, Korea, Republic of
START-Madrid Centro Integral Oncologico Clara Campal
🇪🇸Madrid, Spain
Sir Charles Gairdner Hospital🇦🇺Nedlands, Western Australia, Australia