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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: MYELODYSPLASTIC SYNDROME; MDS; ACUTE MYELOID LEUKEMIA; AML
• Intervention / Treatment: Biological: Humanized anti-CD117 Monoclonal Antibody (JSP191)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Clinical Trials, Jasper Therapeutics, Inc.; Phone Number: 650-549-1417; Email: ClinicalTrials@JasperTherapeutics.com

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope Comprehensive Cancer Center
      • Contact: Nicole Lim, MD, MS; Email: nlim@coh.org
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University
      • Contact: Lori Muffly, MD,MS; Email: lmuffly@stanford.edu
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
      • Contact: Ankur Varma, MD, MPH; Email: ankur_varma@rush.edu
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University
      • Contact: Clinical Trials Information Line; Phone Number: 503-494-1080; Email: trials@ohsu.edu
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • Huntsman Cancer Institute - University of Utah
      • Contact: Catherine Lee, MD; Email: cancerinfo@hci.utah.edu
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutchinson Cancer Research Center
      • Contact: Bart Scott, MD; Email: bscott@fredhutch.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Blood Stem Cell Transplant w/ anti-CD117 conditioning; 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: Jasper Therapeutics, Inc.
• Investigators: 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 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

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2020
• Primary Completion (Anticipated): October 15, 2023
• Study Completion (Anticipated): December 8, 2023

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (Actual): June 12, 2020

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: AML; MDS; ACUTE MYELOID LEUKEMIA; MYELODYSPLASTIC SYNDROME
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Leukemia; Myelodysplastic Syndromes; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Antibodies, Monoclonal
• Other Study ID Numbers: JSP-CP-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No