Clinical Trial 22096

• Overview

  Study 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)

  Summary:

  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).

  Objective:

  The primary objectives of this study are to: - Evaluate the safety, tolerability, and dose-limiting toxicities (DLTs) of JSP191 in multiple doses - Define the MTD or optimal biologic dose (OBD) of JSP191 in subjects with LR-MDS

• Treatments

  Therapies:

  Therapy (NOS)

  Medications:

  JSP191 ()

• Inclusion Criteria

  Inclusion Criteria:
  • Participants must be 18 years of age or older
  • 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 particiipants 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

  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
  • Participants who, in the opinion of the Investigator, may not be able to comply with the requirements of the study

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