Lower-risk Myelodysplastic Syndrome
Conditions
Keywords
LR-MDS, cytopenia
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).
Interventions
DRUGJSP191
Subjects will receive intravenous JSP191
Sponsors
Jasper Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
3 + 3 dose escalation/de-escalation design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of JSP191 | 32 weeks | Assessed by the frequency, duration, and severity of adverse events |
Countries
United States
Outcome results
None listed