JSP191 for MDS/AML

Not currently recruiting at 5 trial locations

Overseen By Clinical Trials, Jasper Therapeutics, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Jasper Therapeutics, Inc.

Must not be taking: Investigational agents

Disqualifiers: Uncontrolled infections, Non-hematologic malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called JSP191 (also known as AMG 191) to determine its safety and tolerability for individuals with certain blood conditions, specifically Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). The treatment combines with low-dose radiation and a medication called fludarabine before patients receive a stem cell transplant. The trial seeks participants with these conditions who plan to undergo a blood stem cell transplant from a matched donor. Participants should not have active infections or other cancers. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot participate if you are receiving any other investigational agents.

Is there any evidence suggesting that JSP191 is likely to be safe for humans?

Research has shown that JSP191 is generally safe and well-tolerated. In studies involving patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), no severe side effects were directly linked to the treatment. Specifically, tests with 24 patients revealed that the treatment did not cause any major health problems. This suggests JSP191 is safe for use with these conditions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about JSP191 because it offers a novel approach to treating MDS (Myelodysplastic Syndromes) and AML (Acute Myeloid Leukemia) by targeting the CD117 receptor, a key player in stem cell survival and proliferation. Unlike traditional chemotherapy or radiation, which can harm healthy cells, JSP191's precision in targeting CD117 aims to minimize damage to non-cancerous cells. This targeted mechanism could potentially improve the safety and effectiveness of stem cell transplants, offering new hope for patients who struggle with the limitations of current treatments.

What evidence suggests that JSP191 might be an effective treatment for MDS or AML?

Research has shown that JSP191 is a promising treatment for patients with Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML). In this trial, participants will receive JSP191 as part of the conditioning regimen before a blood stem cell transplant. Early results from previous studies suggest that JSP191, when combined with low-dose radiation and fludarabine, is safe and generally well-tolerated. In a study involving 24 patients, no severe side effects related to the treatment were reported. JSP191 demonstrated the ability to remove minimal residual disease (MRD), which are leftover cancer cells, in older adults preparing for stem cell transplants. This suggests JSP191 may better prepare patients' bodies for successful transplants. Overall, evidence indicates JSP191 could effectively prepare patients before they receive a stem cell transplant. ^{1 2 3 5 6}

Who Is on the Research Team?

Lori Muffly, MD,MS

Principal Investigator

Stanford University

Andrew Artz, MD,MS

Principal Investigator

City of Hope Medical Center

Bart Scott, MD

Principal Investigator

Fred Hutchinson Cancer Center

Catherine Lee, MD

Principal Investigator

Huntsman Cancer Institute/ University of Utah

Arpita Gandhi, MD

Principal Investigator

Oregon Health and Science University

Ankur Varma, MD,PhD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

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

Exclusion Criteria

Rewritten Criteria: 1. You currently have an infection that is not being treated or managed properly. 2. You are currently receiving an experimental medication for another study. 3. You have an active cancer that is not a blood cancer. 4. You have had a bone marrow transplant using cells from another person.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive JSP191 antibody conditioning regimen in combination with low dose radiation and fludarabine, followed by hematopoietic stem cell transplantation

4-6 weeks

Multiple visits for treatment administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after stem cell transplantation

Up to 1 year

Regular visits for monitoring adverse events and hematopoietic recovery

What Are the Treatments Tested in This Trial?

Interventions

• JSP191

How Is the Trial Designed?

Group I: Blood Stem Cell Transplant w/ anti-CD117 conditioning Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Jasper Therapeutics, Inc.

Lead Sponsor

Trials

7

Recruited

310+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04429191

JSP191 Antibody Conditioning Regimen in MDS/AML ...

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 ...

2.

ir.jaspertx.com

ir.jaspertx.com/news-releases/news-release-details/jasper-therapeutics-announces-updated-data-phase-1-clinical

News Release Details

JSP191 is well tolerated with no treatment-related severe adverse events in 24 patients with myelodysplastic syndrome (MDS) or acute myeloid ...

3.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.7035

Early results of phase 1 study of JSP191, an anti-CD117 ...

These early results are the first to demonstrate that JSP191/TBI/Flu is safe, well-tolerated, and capable of clearing MDS/AML MRD in older adults undergoing ...

4.

ir.jaspertherapeutics.com

ir.jaspertherapeutics.com/news-releases/news-release-details/jasper-therapeutics-announces-jsp191-phase-1b-mdsaml-late

News Release Details

The data from 17 patients over the age of 60 with MDS or AML show JSP191, in combination with low dose radiation and fludarabine conditioning, ...

5.

acutemyeloidleukemianews.com

acutemyeloidleukemianews.com/2021/02/18/jsp191-conditioning-shows-promise-prepare-older-patients-undergoing-stem-cell-transplant-early-data/

JSP191 May Better Prepare Older AML Patients for Stem ...

JSP191 showed promising efficacy as a conditioning agent before stem cell transplant for older patients with acute myeloid leukemia or ...

6.

onclive.com

onclive.com/view/jsp191-plus-fludarabine-and-low-dose-irradiation-produces-promising-early-data-in-mds-aml

JSP191 Plus Fludarabine and Low-Dose Irradiation ...

“JSP191 in combination with fludarabine and low-dose TBI is a novel conditioning platform that appears safe, well tolerated, has demonstrated on ...