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

NCT04429191 | Unknown Phase 1 FDA Drug

• 1 other identifier: JSP-CP-003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 6

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.

Conditions

MYELODYSPLASTIC SYNDROME; MDS; ACUTE MYELOID LEUKEMIA; AML

Keywords

ACUTE MYELOID LEUKEMIA; AML; MDS; MYELODYSPLASTIC SYNDROME

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (1)

Blood Stem Cell Transplant w/ anti-CD117 conditioning

EXPERIMENTAL

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)

Interventions

Humanized anti-CD117 Monoclonal Antibody (JSP191) BIOLOGICAL

Procedure: single intravenous infusion of JSP191 antibody

Also known as: JSP191

Blood Stem Cell Transplant w/ anti-CD117 conditioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with any acute or uncontrolled infections
• Patients receiving any other investigational agents
• Patients with active non-hematologic malignancy
• Prior allogeneic hematologic cell transplantation

Sponsors & Collaborators

• Jasper Therapeutics, Inc.: lead

Study Sites (6)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

RECRUITING

Stanford University

Stanford, California, 94305, United States

RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Huntsman Cancer Institute - University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Refractory, with Excess of Blasts; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Anemia, Refractory; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials, Jasper Therapeutics, Inc.

CONTACT

650-549-1417; ClinicalTrials@JasperTherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: July 8, 2020
• Primary Completion: October 15, 2023
• Study Completion: December 8, 2023
• Last Updated: June 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)