NCT05903274

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)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Jasper Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

An open-label, single-arm, dose-escalation study designed to determine the potential safety, efficacy, maximum tolerated dose (MTD) or optimal biologic dose (OBD), and recommended phase 2 dose (RP2D) of JSP191 (briquilimab) monotherapy for LR-MDS subjects with documented cytopenia (red blood cell-transfusion dependent, thrombocytopenia, and/or neutropenia).

Conditions

• Lower-risk Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	JSP191	Subjects will receive intravenous JSP191

Timeline

• Start date: 2023-06-19
• Primary completion: 2024-10-21
• Completion: 2024-10-21
• First posted: 2023-06-15
• Last updated: 2025-02-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study