A Phase 1 Study of JSP191 (Briquilimab) in Subjects With LR-MDS

• Status: Recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 1 study in subjects with LR-MDS to assess the safety and tolerability of JSP191 as a second-line therapy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jasper Therapeutics, Inc.

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