Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-24 @ 9:32 PM
NCT ID:
NCT06331832
Eligibility Criteria:
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.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06331832
Study Brief:
Protocol Section:
NCT06331832