JSP191 (briquilimab) in Subjects with LR-MDS

Launched by JASPER THERAPEUTICS, INC. · Jun 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called JSP191 (Briquilimab) for adults with lower-risk myelodysplastic syndrome (LR-MDS), a condition where the bone marrow doesn’t produce enough healthy blood cells. The main goal of the trial is to evaluate how safe and tolerable this treatment is for patients who have not responded well to other therapies. The study is currently looking for participants aged 18 and older, who have specific types of LR-MDS and are experiencing symptoms related to low blood cell counts.

To participate in this trial, individuals must meet certain criteria, such as having a diagnosis of LR-MDS with very low, low, or intermediate risk features and being willing to follow specific guidelines regarding pregnancy and contraception if applicable. Participants can expect close monitoring throughout the study and may receive JSP191 as a second-line therapy. It’s important to know that this trial is focused on safety, so researchers will carefully observe how well patients tolerate the treatment. If you or someone you know is interested, it’s essential to discuss this with a healthcare provider to see if this trial might be a good fit.

Gender

ALL

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