JSP191 (Briquilimab) in Subjects With LR-MDS
Lower-risk Myelodysplastic Syndrome
About this trial
This is an interventional treatment trial for Lower-risk Myelodysplastic Syndrome focused on measuring LR-MDS, cytopenia
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years MDS with IPSS-R very low, low, or intermediate risk features Symptomatic cytopenias Women of childbearing potential (WOCBP) must agree to use an oral or implanted contraceptive, a double-barrier method of birth control, or an intrauterine device upon enrollment and through 3 months after receiving the last dose of JSP191 Women not of childbearing potential must be post-menopausal (no menstrual period for a minimum of 12 months) or surgically sterilized and have a negative serum pregnancy test upon study entry Male subjects must be surgically sterile or willing to use contraception upon enrollment and through 3 months after receiving the last dose of JSP191 Must be willing and able to provide informed consent Exclusion Criteria: Anemia secondary to iron deficiency, vitamin B12 deficiency, or folate deficiency Prior allogeneic or autologous stem cell transplant Known history of human immunodeficiency virus (HIV) (no laboratory testing is required), or active infection with hepatitis B or hepatitis C Pregnant women or women who are nursing and do not wish to discontinue breastfeeding Any other medical condition that, in the opinion of the Investigator, could pose a significant safety risk to the subject or jeopardize the integrity of the study Subjects who, in the opinion of the Investigator, may not be able to comply with the requirements of the study
Sites / Locations
- Moffitt Cancer CenterRecruiting
Arms of the Study
Arm 1
Experimental
JSP191
This study will explore up to 5 ascending dose levels (Cohorts 1, 2, 3, 4, and 5) and subjects will receive JSP191 on Day 1 on each 8-week cycle for 4 consecutive cycles.