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

ACUTE MYELOID LEUKEMIA; AML Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04429191
• Other study ID #: JSP-CP-003
• Status: Recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• ACUTE MYELOID LEUKEMIA; AML
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• MYELODYSPLASTIC SYNDROME; MDS
• Myelodysplastic Syndromes
• Preleukemia

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)