JSP191 (briquilimab) in Subjects with LR-MDS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-19

Study Completion Date

2024-10-21

Brief Summary

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

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Detailed Description

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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

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Lower-risk Myelodysplastic Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

3 + 3 dose escalation/de-escalation design

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

JSP191

Intervention Type DRUG

Subjects will receive intravenous JSP191

Interventions

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JSP191

Subjects will receive intravenous JSP191

Intervention Type DRUG

Other Intervention Names

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JSP191 (Briquilimab)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No