JSP191 (Briquilimab) in Subjects With LR-MDS

Trial Title: JSP191 (Briquilimab) in Subjects With LR-MDS

NCT ID: NCT05903274

Condition: Lower-risk Myelodysplastic Syndrome

Conditions: Official terms:
Preleukemia
Myelodysplastic Syndromes
Syndrome

Conditions: Keywords:
LR-MDS
cytopenia

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Sequential Assignment

Intervention model description: 3 + 3 dose escalation/de-escalation design

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: JSP191
Description: Subjects will receive intravenous JSP191
Arm group label: JSP191

Other name: JSP191 (Briquilimab)

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).

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Memorial Healthcare System

Address:
City: Hollywood
Zip: 33021
Country: United States

Status: Recruiting

Facility:
Name: Moffitt Cancer Center

Address:
City: Tampa
Zip: 33612
Country: United States

Status: Recruiting

Start date: June 19, 2023

Completion date: July 2025

Lead sponsor:
Agency: Jasper Therapeutics, Inc.
Agency class: Industry

Source: Jasper Therapeutics, Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05903274
https://www.jaspertherapeutics.com/