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JSP191 (Briquilimab) in Subjects With LR-MDS

Primary Purpose

Lower-risk Myelodysplastic Syndrome

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
JSP191
Sponsored by
Jasper Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower-risk Myelodysplastic Syndrome focused on measuring LR-MDS, cytopenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Moffitt Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

JSP191

Arm Description

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.

Outcomes

Primary Outcome Measures

Safety and tolerability of JSP191
Assessed by the frequency, duration, and severity of adverse events

Secondary Outcome Measures

Full Information

First Posted
June 5, 2023
Last Updated
June 20, 2023
Sponsor
Jasper Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05903274
Brief Title
JSP191 (Briquilimab) in Subjects With LR-MDS
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jasper Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower-risk Myelodysplastic Syndrome
Keywords
LR-MDS, cytopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
3 + 3 dose escalation/de-escalation design
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
JSP191
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
JSP191
Other Intervention Name(s)
JSP191 (Briquilimab)
Intervention Description
Subjects will receive intravenous JSP191
Primary Outcome Measure Information:
Title
Safety and tolerability of JSP191
Description
Assessed by the frequency, duration, and severity of adverse events
Time Frame
32 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Hinds
Phone
650-549-1400
Email
dhinds@jaspertherapeutics.com
First Name & Middle Initial & Last Name or Official Title & Degree
Michele Laurel
Phone
650-549-1400
Email
mlaurel@jaspertherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Hinds
Organizational Affiliation
Jasper Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Links:
URL
https://www.jaspertherapeutics.com/
Description
Related Info

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JSP191 (Briquilimab) in Subjects With LR-MDS

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