<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04429191</url>
  </required_header>
  <id_info>
    <org_study_id>JSP-CP-003</org_study_id>
    <nct_id>NCT04429191</nct_id>
  </id_info>
  <brief_title>JSP191 Antibody Conditioning Regimen in MDS/AML Subjects Undergoing Allogenic Hematopoietic Stem Cell Transplantation</brief_title>
  <official_title>A Phase 1a/b Study to Evaluate the Safety &amp; Tolerability of JSP191 in Combination With a Regimen of Low Dose Radiation &amp; Fludarabine in Subjects With MDS or AML Undergoing Hematopoietic Cell Transplantation (HCT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jasper Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jasper Therapeutics, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 1a/b study to evaluate the safety and tolerability of an antibody&#xD;
      conditioning regimen known as JSP191, in combination with low dose radiation and fludarabine,&#xD;
      in subjects with Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) undergoing&#xD;
      allogenic blood stem cell transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 1a/b study to evaluate the safety and tolerability of an antibody&#xD;
      conditioning regimen known as JSP191, in combination with low dose radiation and fludarabine&#xD;
      in subjects with Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) undergoing&#xD;
      allogenic blood stem cell transplantation.&#xD;
&#xD;
      Blood Stem Cell transplantation offers the only potentially curative therapy for many forms&#xD;
      of Acute Myeloid Leukemia (AML) and for Myelodysplastic Syndrome (MDS). While standard of&#xD;
      care conditioning regimens given prior to blood Stem Cell transplantation, such as standard&#xD;
      TBI/Flu conditioning are well tolerated, they are associated with increased rates of relapse&#xD;
      due to persistence of disease causing Hematopoietic Stem Cells and insufficient graft versus&#xD;
      leukemia effect.&#xD;
&#xD;
      The biological conditioning regimen JSP191 is an antibody that binds to CD117. CD117 is the&#xD;
      receptor for Stem Cell Factor on blood forming cells. CD117 binding to Stem Cell Factor is&#xD;
      critical for survival and maintenance of blood forming stem cells.&#xD;
&#xD;
      The binding of JSP191 to CD117 blocks CD117 from binding to Stem Cell Factor on blood forming&#xD;
      stem cells. In the absence of CD117/Stem Cell Factor binding, hematopoietic stem cells that&#xD;
      are currently occupying the bone marrow niches in MDS/AML patients are depleted.&#xD;
&#xD;
      This study will investigate the safety and tolerability of adding JSP191 (an anti-CD117&#xD;
      monoclonal antibody therapy) to standard TBI/Flu conditioning regimen in adults with AML and&#xD;
      MDS undergoing hematopoietic stem cell transplant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 8, 2020</start_date>
  <completion_date type="Anticipated">December 8, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 15, 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of subjects experiencing adverse events and serious adverse events will be assessed.</measure>
    <time_frame>Up to 1 year post Donor Cell Transplant (28 days dose limiting toxicity period)</time_frame>
    <description>The number of subjects experiencing adverse events and serious adverse events will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of dose limiting toxicities will be assessed.</measure>
    <time_frame>Up to 1 year post Donor Cell Transplant (28 days dose limiting toxicity period)</time_frame>
    <description>The number of dose limiting toxicities will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The type of dose limiting toxicities will be assessed.</measure>
    <time_frame>Up to 1 year post Donor Cell Transplant (28 days dose limiting toxicity period)</time_frame>
    <description>The type of dose limiting toxicities will be assessed.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>MYELODYSPLASTIC SYNDROME; MDS</condition>
  <condition>ACUTE MYELOID LEUKEMIA; AML</condition>
  <arm_group>
    <arm_group_label>Blood Stem Cell Transplant w/ anti-CD117 conditioning</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The phase 1a portion of the study plans to assess approximately 3 planned dose cohorts of JSP191: 0.3 mg/kg, 0.6 mg/kg, and 1.0 mg/kg to determine the maximum tolerated dose for expansion. Subjects 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.&#xD;
The phase 1b portion of the study will enroll additional subjects at the expansion dose in order to further explore the safety, feasibility, and PK of that dose.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Humanized anti-CD117 Monoclonal Antibody (JSP191)</intervention_name>
    <description>Procedure: single intravenous infusion of JSP191 antibody</description>
    <arm_group_label>Blood Stem Cell Transplant w/ anti-CD117 conditioning</arm_group_label>
    <other_name>JSP191</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  AML/MDS as defined by specific criteria, including but not limited to the following&#xD;
             subtypes:&#xD;
&#xD;
               1. AML in CR&#xD;
&#xD;
               2. MDS &lt; 5% BM blasts&#xD;
&#xD;
               3. MDS 5 - 10% BM blasts&#xD;
&#xD;
               4. AML not in CR or MDS &gt; 10% BM blasts&#xD;
&#xD;
          -  Patients with human leukocyte antigen (HLA) matched related or unrelated donors&#xD;
&#xD;
          -  Adequate end organ function as defined in study protocol&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Patients with any acute or uncontrolled infections&#xD;
&#xD;
          -  Patients receiving any other investigational agents&#xD;
&#xD;
          -  Patients with active non-hematologic malignancy&#xD;
&#xD;
          -  Prior allogeneic hematologic cell transplantation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lori Muffly, MD,MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andrew Artz, MD,MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>City of Hope Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bart Scott, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutchinson Cancer Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Catherine Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Huntsman Cancer Institute/ University of Utah</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Arpita Gandhi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ankur Varma, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rush University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Clinical Trials, Jasper Therapeutics, Inc.</last_name>
    <phone>650-549-1417</phone>
    <email>ClinicalTrials@JasperTherapeutics.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>City of Hope Comprehensive Cancer Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicole Lim, MD, MS</last_name>
      <email>nlim@coh.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lori Muffly, MD,MS</last_name>
      <email>lmuffly@stanford.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ankur Varma, MD, MPH</last_name>
      <email>ankur_varma@rush.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clinical Trials Information Line</last_name>
      <phone>503-494-1080</phone>
      <email>trials@ohsu.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute - University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catherine Lee, MD</last_name>
      <email>cancerinfo@hci.utah.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fred Hutchinson Cancer Research Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bart Scott, MD</last_name>
      <email>bscott@fredhutch.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 8, 2021</last_update_submitted>
  <last_update_submitted_qc>June 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ACUTE MYELOID LEUKEMIA</keyword>
  <keyword>AML</keyword>
  <keyword>MDS</keyword>
  <keyword>MYELODYSPLASTIC SYNDROME</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
    <mesh_term>Preleukemia</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04429191
org study id: JSP-CP-003
nct id: NCT04429191
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 1a/b study to evaluate the safety and tolerability of an antibody
      conditioning regimen known as JSP191, in combination with low dose radiation and fludarabine,
      in subjects with Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) undergoing
      allogenic blood stem cell transplantation.
This is a Phase 1a/b study to evaluate the safety and tolerability of an antibody
      conditioning regimen known as JSP191, in combination with low dose radiation and fludarabine
      in subjects with Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) undergoing
      allogenic 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 are 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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
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)
description: The number of subjects experiencing adverse events and serious adverse events will be assessed.
measure: The number of dose limiting toxicities will be assessed.
time frame: Up to 1 year post Donor Cell Transplant (28 days dose limiting toxicity period)
description: The number of dose limiting toxicities will be assessed.
measure: The type of dose limiting toxicities will be assessed.
time frame: Up to 1 year post Donor Cell Transplant (28 days dose limiting toxicity period)
description: The type of dose limiting toxicities will be assessed.
arm group label: Blood Stem Cell Transplant w/ anti-CD117 conditioning
arm group type: Experimental
description: The phase 1a portion of the study plans to assess approximately 3 planned dose cohorts of JSP191: 0.3 mg/kg, 0.6 mg/kg, and 1.0 mg/kg to determine the maximum tolerated dose for expansion. Subjects 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.
The phase 1b portion of the study will enroll additional subjects at the expansion dose in order to further explore the safety, feasibility, and PK of that dose.
intervention type: Biological
intervention name: Humanized anti-CD117 Monoclonal Antibody (JSP191)
description: Procedure: single intravenous infusion of JSP191 antibody
arm group label: Blood Stem Cell Transplant w/ anti-CD117 conditioning
other name: JSP191
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lori Muffly, MD,MS
role: Principal Investigator
affiliation: Stanford University
last name: Andrew Artz, MD,MS
role: Principal Investigator
affiliation: City of Hope Medical Center
last name: Bart Scott, MD
role: Principal Investigator
affiliation: Fred Hutchinson Cancer Center
last name: Catherine Lee, MD
role: Principal Investigator
affiliation: Huntsman Cancer Institute/ University of Utah
last name: Arpita Gandhi, MD
role: Principal Investigator
affiliation: Oregon Health and Science University
last name: Ankur Varma, MD,PhD
role: Principal Investigator
affiliation: Rush University Medical Center
last name: Clinical Trials, Jasper Therapeutics, Inc.
phone: 650-549-1417
email: ClinicalTrials@JasperTherapeutics.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Preleukemia
mesh term: Myelodysplastic Syndromes
mesh term: Antibodies
mesh term: Antibodies, Monoclonal
sharing ipd: No