Clinical Trials /

JSP191 Antibody Targeting Conditioning in MDS/AML Patients Undergoing Hematopoietic Cell Transplantation

NCT04429191

Description:

This is a Phase 1 study to evaluate the safety and tolerability of an antibody conditioning regimen known as JSP191, in combination with low dose radiation and fludarabine, in patients with Myelodysplastic Syndrome or Acute Myeloid Leukemia undergoing blood stem cell transplantation

Related Conditions:
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: JSP191 Antibody Targeting Conditioning in MDS/AML Patients Undergoing Hematopoietic Cell Transplantation
  • Official Title: A Phase 1 Study to Evaluate the Safety and Tolerability of JSP191 in Combination With Low Dose Radiation and Fludarabine in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Undergoing Hematopoietic Cell Transplantation

Clinical Trial IDs

  • ORG STUDY ID: JSP-CP-003
  • NCT ID: NCT04429191

Conditions

  • MYELODYSPLASTIC SYNDROME; MDS
  • ACUTE MYELOID LEUKEMIA; AML

Interventions

DrugSynonymsArms
Humanized anti-CD117 Monoclonal Antibody (JSP191)JSP191Blood Stem Cell Transplant w/ anti-CD117 conditioning

Purpose

This is a Phase 1 study to evaluate the safety and tolerability of an antibody conditioning regimen known as JSP191, in combination with low dose radiation and fludarabine, in patients with Myelodysplastic Syndrome or Acute Myeloid Leukemia undergoing blood stem cell transplantation

Detailed Description

      This is a Phase 1 study to evaluate the safety and tolerability of an antibody conditioning
      regimen known as JSP191, in combination with low dose radiation and fludarabine, in patients
      with Myelodysplastic Syndrome or Acute Myeloid Leukemia undergoing blood stem cell
      transplantation.

      Blood Stem Cell transplantation offers the only potentially curative therapy for many forms
      of Acute Myeloid Leukemia (AML) and for Myelodysplastic Syndrome (MDS). While standard of
      care conditioning regimens given prior to blood Stem Cell transplantation, such as standard
      TBI/Flu conditioning is well tolerated, they are associated with increased rates of relapse
      due to persistence of disease causing Hematopoietic Stem Cells and insufficient graft versus
      leukemia effect.

      The biological conditioning regimen, JSP191, is an antibody that binds to CD117. CD117 is the
      receptor for Stem Cell Factor on blood forming cells. CD117 binding to Stem Cell Factor is
      critical for survival and maintenance of blood forming stem cells.

      The binding of JSP191 to CD117 blocks CD117 from binding to Stem Cell Factor on blood forming
      stem cells. In the absence of CD117/Stem Cell Factor binding, hematopoietic stem cells that
      are currently occupying the bone marrow niches in MDS/AML patients are depleted.

      This study will investigate the safety and tolerability of adding JSP191 (an anti-CD117
      monoclonal antibody therapy) to standard TBI/Flu conditioning regimen in adults with AML and
      MDS undergoing hematopoietic stem cell transplant.
    

Trial Arms

NameTypeDescriptionInterventions
Blood Stem Cell Transplant w/ anti-CD117 conditioningExperimentalThe study plans to assess approximately 3 planned dose cohorts of JSP191: 0.3 mg/kg, 0.6 mg/kg, and 1.0 mg/kg. Patients will receive a single dose of intravenous JSP191 antibody followed by monitoring for antibody clearance. Once the antibody has cleared below a certain level, patients will receive stem cell transplant and be monitored for hematopoietic recovery.
  • Humanized anti-CD117 Monoclonal Antibody (JSP191)

Eligibility Criteria

        Key Inclusion Criteria:

          -  AML/MDS as defined by specific criteria, including but not limited to the following
             subtypes:

               1. AML in CR, Flt3+ MRD+

               2. AML in CR, Flt3- MRD+

               3. MDS < 5% BM blasts, MID/MRD+

               4. MDS 5 - 10% BM blasts

          -  Patients with human leukocyte antigen (HLA) matched related or unrelated donors

          -  Adequate end organ function as defined in study protocol

        Key Exclusion Criteria:

          -  Patients with any acute or uncontrolled infections

          -  Patients receiving any other investigational agents

          -  Patients with active non-hematologic malignancy

          -  Prior allogeneic hematologic cell transplantation
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:The number of subjects experiencing adverse events and serious adverse events will be assessed.
Time Frame:Up to 1 year post Donor Cell Transplant (28 days dose limiting toxicity period)
Safety Issue:
Description:The number of subjects experiencing dose limiting toxicities including adverse events and serious adverse events will be assessed.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Jasper Therapeutics, Inc.

Trial Keywords

  • ACUTE MYELOID LEUKEMIA
  • AML
  • MDS
  • MYELODYSPLASTIC SYNDROME

Last Updated

July 16, 2020