JSP191 (Briquilimab) in Subjects With LR-MDS

Sponsor

Jasper Therapeutics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05903274

Collaborator

(none)

Enrollment

Location

Arm

24.4

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Lower-risk Myelodysplastic Syndrome	Drug: JSP191	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Intervention Model Description:

3 + 3 dose escalation/de-escalation design3 + 3 dose escalation/de-escalation design

Masking:

None (Open Label)

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 :

Jun 19, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JSP191 This 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.	Drug: JSP191 Subjects will receive intravenous JSP191 Other Names: JSP191 (Briquilimab)

Arm

Intervention/Treatment

Experimental: JSP191

This 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.

Drug: JSP191

Subjects will receive intravenous JSP191

Other Names:

JSP191 (Briquilimab)

Outcome Measures

Primary Outcome Measures

Safety and tolerability of JSP191 [32 weeks]
Assessed by the frequency, duration, and severity of adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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