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JSP191 Antibody Conditioning Regimen in MDS/AML Subjects Undergoing Allogenic Hematopoietic Stem Cell Transplantation

Primary Purpose

MYELODYSPLASTIC SYNDROME; MDS, ACUTE MYELOID LEUKEMIA; AML

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Humanized anti-CD117 Monoclonal Antibody (JSP191)
Sponsored by
Jasper Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for MYELODYSPLASTIC SYNDROME; MDS focused on measuring ACUTE MYELOID LEUKEMIA, AML, MDS, MYELODYSPLASTIC SYNDROME

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

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

    1. AML in CR
    2. MDS < 5% BM blasts
    3. MDS 5 - 10% BM blasts
    4. AML not in CR or MDS > 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

Sites / Locations

  • City of Hope Comprehensive Cancer CenterRecruiting
  • Stanford UniversityRecruiting
  • Rush University Medical CenterRecruiting
  • Oregon Health & Science UniversityRecruiting
  • Huntsman Cancer Institute - University of UtahRecruiting
  • Fred Hutchinson Cancer Research CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Blood Stem Cell Transplant w/ anti-CD117 conditioning

Arm 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.

Outcomes

Primary Outcome Measures

The number of subjects experiencing adverse events and serious adverse events will be assessed.
The number of subjects experiencing adverse events and serious adverse events will be assessed.
The number of dose limiting toxicities will be assessed.
The number of dose limiting toxicities will be assessed.
The type of dose limiting toxicities will be assessed.
The type of dose limiting toxicities will be assessed.

Secondary Outcome Measures

Full Information

First Posted
June 10, 2020
Last Updated
June 8, 2021
Sponsor
Jasper Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04429191
Brief Title
JSP191 Antibody Conditioning Regimen in MDS/AML Subjects Undergoing Allogenic Hematopoietic Stem Cell Transplantation
Official Title
A Phase 1a/b Study to Evaluate the Safety & Tolerability of JSP191 in Combination With a Regimen of Low Dose Radiation & Fludarabine in Subjects With MDS or AML Undergoing Hematopoietic Cell Transplantation (HCT)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2020 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
December 8, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jasper Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MYELODYSPLASTIC SYNDROME; MDS, ACUTE MYELOID LEUKEMIA; AML
Keywords
ACUTE MYELOID LEUKEMIA, AML, MDS, MYELODYSPLASTIC SYNDROME

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blood Stem Cell Transplant w/ anti-CD117 conditioning
Arm Type
Experimental
Arm 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(s)
Humanized anti-CD117 Monoclonal Antibody (JSP191)
Other Intervention Name(s)
JSP191
Intervention Description
Procedure: single intravenous infusion of JSP191 antibody
Primary Outcome Measure Information:
Title
The number of subjects experiencing adverse events and serious adverse events will be assessed.
Description
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)
Title
The number of dose limiting toxicities will be assessed.
Description
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)
Title
The type of dose limiting toxicities will be assessed.
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: AML/MDS as defined by specific criteria, including but not limited to the following subtypes: AML in CR MDS < 5% BM blasts MDS 5 - 10% BM blasts AML not in CR or MDS > 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials, Jasper Therapeutics, Inc.
Phone
650-549-1417
Email
ClinicalTrials@JasperTherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori Muffly, MD,MS
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Artz, MD,MS
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bart Scott, MD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Catherine Lee, MD
Organizational Affiliation
Huntsman Cancer Institute/ University of Utah
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arpita Gandhi, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ankur Varma, MD,PhD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Lim, MD, MS
Email
nlim@coh.org
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori Muffly, MD,MS
Email
lmuffly@stanford.edu
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ankur Varma, MD, MPH
Email
ankur_varma@rush.edu
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Information Line
Phone
503-494-1080
Email
trials@ohsu.edu
Facility Name
Huntsman Cancer Institute - University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Lee, MD
Email
cancerinfo@hci.utah.edu
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bart Scott, MD
Email
bscott@fredhutch.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

JSP191 Antibody Conditioning Regimen in MDS/AML Subjects Undergoing Allogenic Hematopoietic Stem Cell Transplantation

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