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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/