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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04429191
Recruitment Status : Recruiting
First Posted : June 12, 2020
Last Update Posted : July 17, 2020
Sponsor:
Information provided by (Responsible Party):
Jasper Therapeutics, Inc.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
MYELODYSPLASTIC SYNDROME; MDS ACUTE MYELOID LEUKEMIA; AML Biological: Humanized anti-CD117 Monoclonal Antibody (JSP191) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 8, 2020
Estimated Primary Completion Date : February 15, 2021
Estimated Study Completion Date : May 8, 2021


Arm Intervention/treatment
Experimental: Blood Stem Cell Transplant w/ anti-CD117 conditioning
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. 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.
Biological: Humanized anti-CD117 Monoclonal Antibody (JSP191)
Procedure: single intravenous infusion of JSP191 antibody
Other Name: JSP191




Primary Outcome Measures :
  1. 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) ]
    The number of subjects experiencing dose limiting toxicities including adverse events and serious adverse events will be assessed.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04429191


Contacts
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Contact: Clinical Trials, Jasper Therapeutics, Inc. 650-549-1417 ClinicalTrials@JasperTherapeutics.com

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Lori Muffly, MD,MS       lmuffly@stanford.edu   
Sponsors and Collaborators
Jasper Therapeutics, Inc.
Investigators
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Principal Investigator: Lori Muffly, MD,MS Stanford University
Principal Investigator: Andrew Artz, MD,MS City of Hope Medical Center
Principal Investigator: Bart Scott, MD Fred Hutchinson Cancer Research Center
Principal Investigator: Catherine Lee, MD Huntsman Cancer Institute/ University of Utah
Principal Investigator: Arpita Gandhi, MD Oregon Health and Science University
Principal Investigator: Ankur Varma, MD,PhD Rush University Medical Center
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Responsible Party: Jasper Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04429191    
Other Study ID Numbers: JSP-CP-003
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jasper Therapeutics, Inc.:
ACUTE MYELOID LEUKEMIA
AML
MDS
MYELODYSPLASTIC SYNDROME
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs