Study Stopped
The study was terminated due to a lack of improvement in clinical efficacy outcomes.
JSP191 (briquilimab) in Subjects with LR-MDS
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)
1 other identifier
interventional
6
1 country
2
Brief Summary
A Phase 1 study in subjects with LR-MDS to assess the safety and tolerability of JSP191 as a second-line therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedStudy Start
First participant enrolled
June 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 21, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 21, 2024
CompletedFebruary 27, 2025
February 1, 2025
1.3 years
June 5, 2023
February 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability of JSP191
Assessed by the frequency, duration, and severity of adverse events
32 weeks
Study Arms (1)
JSP191
EXPERIMENTALThis 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Memorial Healthcare System
Hollywood, Florida, 33021, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Jasper Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2023
First Posted
June 15, 2023
Study Start
June 19, 2023
Primary Completion
October 21, 2024
Study Completion
October 21, 2024
Last Updated
February 27, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share