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
2 other identifiers
expanded_access
N/A
3 countries
3
Brief Summary
Expanded Access of Imvotamab (IGM-2323) in Patients with Relapsed/Refractory Non-Hodgkin Lymphomas from IGM-2323-001 clinical trial.
Trial Health
Trial Health Score
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3 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2024
CompletedFirst Posted
Study publicly available on registry
March 26, 2024
CompletedMarch 26, 2024
March 1, 2024
March 19, 2024
March 19, 2024
Conditions
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Samsung Medical Center
Seoul, Gangnam-gu, South Korea
START-Madrid Centro Integral Oncologico Clara Campal
Madrid, Spain