Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05903274 | TERMINATED | Lower-risk Myelodysplastic Syndrome

JSP191 (briquilimab) in Subjects with LR-MDS
Sponsor:

Jasper Therapeutics, Inc.

Brief Summary:

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

Condition or disease

Lower-risk Myelodysplastic Syndrome

Intervention/treatment

JSP191

Phase

PHASE1

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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 6 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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)
Actual Study Start Date : 2023-06-19
Estimated Primary Completion Date : 2024-10-21
Estimated Study Completion Date : 2024-10-21

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
JSP191 (briquilimab) in Subjects with LR-MDS

Location Details

NCT05903274

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Florida

Memorial Healthcare System

Hollywood, Florida, United States, 33021

Not yet recruiting

United States, Florida

Moffitt Cancer Center

Tampa, Florida, United States, 33612