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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04429191
Other study ID # JSP-CP-003
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date July 8, 2020
Est. completion date December 8, 2023

Study information

Verified date June 2021
Source Jasper Therapeutics, Inc.
Contact Clinical Trials, Jasper Therapeutics, Inc.
Phone 650-549-1417
Email ClinicalTrials@JasperTherapeutics.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 8, 2023
Est. primary completion date October 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Biological:
Humanized anti-CD117 Monoclonal Antibody (JSP191)
Procedure: single intravenous infusion of JSP191 antibody

Locations

Country Name City State
United States Rush University Medical Center Chicago Illinois
United States City of Hope Comprehensive Cancer Center Duarte California
United States Oregon Health & Science University Portland Oregon
United States Huntsman Cancer Institute - University of Utah Salt Lake City Utah
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Stanford University Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Jasper Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 1 year post Donor Cell Transplant (28 days dose limiting toxicity period)
Primary The number of dose limiting toxicities will be assessed. The number of dose limiting toxicities will be assessed. Up to 1 year post Donor Cell Transplant (28 days dose limiting toxicity period)
Primary The type of dose limiting toxicities will be assessed. The type of dose limiting toxicities will be assessed. Up to 1 year post Donor Cell Transplant (28 days dose limiting toxicity period)
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06387420 - A Study of AK117 in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia Phase 1/Phase 2