Recruiting
Phase 1

JSP191

Sponsor:

Jasper Therapeutics, Inc.

Code:

NCT04429191

Conditions

MYELODYSPLASTIC SYNDROME; MDS

ACUTE MYELOID LEUKEMIA; AML

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Humanized anti-CD117 Monoclonal Antibody (JSP191)

Study Details

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

Study ID

NCT04429191

Start date

Jul 8, 2020

Status verified date

Jun, 2021

Completion date

Dec 8, 2023

Anticipated

Primary completion date

Oct 15, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Humanized anti-CD117 Monoclonal Antibody (JSP191)

Procedure: single intravenous infusion of JSP191 antibody

Primary outcome measure

  • 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) ]
  • 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Clinical Trials, Jasper Therapeutics, Inc.

650-549-1417ClinicalTrials@JasperTherapeutics.com

Locations

City of Hope Comprehensive Cancer Center

Recruiting

Duarte, California, United States, 91010

Contacts

Nicole Lim, MD, MS

nlim@coh.org

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Lori Muffly, MD,MS

lmuffly@stanford.edu

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Ankur Varma, MD, MPH

ankur_varma@rush.edu

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Clinical Trials Information Line

503-494-1080trials@ohsu.edu

Huntsman Cancer Institute - University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Catherine Lee, MD

cancerinfo@hci.utah.edu

Fred Hutchinson Cancer Research Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Bart Scott, MD

bscott@fredhutch.org

More Information

Sponsor

Jasper Therapeutics, Inc.

Last update posted

Jun 11, 2021

Last verified

Jun, 2021

Keywords

  • ACUTE MYELOID LEUKEMIA
  • AML
  • MDS
  • MYELODYSPLASTIC SYNDROME

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jasper Therapeutics, Inc. on 2021-06-11.