JSP191 (briquilimab) in Subjects with LR-MDS
Reason given: The study was terminated due to a lack of improvement in clinical efficacy outcomes.
Key facts
- Where
- Hollywood and Tampa, United StatesSee the 2 sites
- Phase
- Phase 1
Where in United States
- Memorial Healthcare SystemHollywood, United StatesNo longer taking part
- Moffitt Cancer CenterTampa, United StatesNo longer taking part
Trial details
- Who runs it
- Jasper Therapeutics, Inc.
- Trial code
- NCT05903274
- Record updated
- 27 February 2025
- Original description
A Phase 1 study in subjects with LR-MDS to assess the safety and tolerability of JSP191 as a second-line therapy.Read full original descriptionShow less
A Phase 1 Open-label, Dose-escalation, Safety, and Tolerability Study of JSP191 As a Second-line Therapy in Subjects with Lower-Risk Myelodysplastic Syndrome (LR-MDS)
A Phase 1 study in subjects with LR-MDS to assess the safety and tolerability of JSP191 as a second-line therapy.
Inclusion: 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: Prior allogeneic or autologous stem cell transplant; 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; Known history of human immunodeficiency virus (HIV) (no laboratory testing is required), or active infection with hepatitis B or hepatitis C; Anemia secondary to iron deficiency, vitamin B12 deficiency, or folate deficiency; Pregnant women or women who are nursing and do not wish to discontinue breastfeeding; Subjects who, in the opinion of the Investigator, may not be able to comply with the requirements of the study.