JSP191 for MDS/AML

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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests JSP191, an antibody that helps clear out diseased blood cells, in adults with MDS or AML who are getting a stem cell transplant. By blocking a critical connection on blood cells, JSP191 makes room for new, healthy stem cells.

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.

What makes the drug JSP191 unique for treating MDS/AML?

JSP191 is unique because it targets a specific protein on blood stem cells, potentially offering a more precise approach compared to traditional treatments that affect a broader range of cells. This targeted mechanism may reduce side effects and improve outcomes for patients with MDS/AML. ^{1 2 3 4 5}

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

Eligibility Criteria

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

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

Treatment Details

Interventions

• JSP191

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

SF3B1 mutated MDS: Blast count, genetic co-abnormalities and their impact on classification and prognosis. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Hypomethylating agents (HMAs) show benefit in AML rather than in intermediate/high-risk MDS based on genetic mutations in epigenetic modification (EMMs): from a retrospective study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Whole-exome and targeted sequencing identify ROBO1 and ROBO2 mutations as progression-related drivers in myelodysplastic syndromes. [2023]

4. Italy pubmed.ncbi.nlm.nih.gov

Unique ethnic features of DDX41 mutations in patients with idiopathic cytopenia of undetermined significance, myelodysplastic syndrome, or acute myeloid leukemia. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The changing mutational landscape of acute myeloid leukemia and myelodysplastic syndrome. [2021]