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)

Overview

A Phase 1 study in subjects with LR-MDS to assess the safety and tolerability of JSP191 as a second-line therapy.
SparkCures ID 1751
Trial Phase Phase 1
Enrollment 6 Patients
Treatments
Tags
Trial Sponsors
  • Jasper Therapeutics, Inc.
NCT Identifier

NCT05903274

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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

US Trial Locations

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Trial Links

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