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) JSP191 (BRIQUILIMAB)

What's the purpose of this trial?

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

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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

Additional Trial Information

Phase 1

Enrollment: 30 patients (estimated)

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Trial Locations

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Florida

Memorial Cancer Institute Memorial Regional Hospital

Hollywood, FL

Open and Accepting

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Open and Accepting
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