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) JSP191 CONDITIONING REGIMEN

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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

Additional Trial Information

Phase 1

Enrollment: 40 patients (estimated)

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Published Results

Early results of phase 1 study of JSP191, an anti-CD117 monoclonal antibody, with non-myeloablative conditioning in older adults with MRD-positive MDS/AML undergoing allogeneic hematopoietic cell transplantation

May 28, 2021

All subjects are still on trial, and there have been no infusion toxicities and no JSP191-related serious adverse events. All subjects engrafted with neutrophil recovery TD+19 to TD+26, and showed ≥94% donor myeloid chimerism in the blood at TD+28. All 3 evaluable subjects with TD+90 follow up showed complete donor (≥95%) total and myeloid chimerism and MRD elimination.

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Open and Accepting

Stanford Cancer Institute (Palo Alto)

Stanford, CA

Open and Accepting

Illinois

Rush University Medical Center

Chicago, IL

Open and Accepting

Oregon

Oregon Health and Science University OHSU Knight Cancer Institute

Portland, OR

Open and Accepting

Utah

Huntsman Cancer Institute University of Utah

Salt Lake City, UT

Open and Accepting

Washington

Fred Hutchinson / University of Washington Cancer Consortium Seattle Cancer Care Alliance (SCCA)

Seattle, WA

Open and Accepting
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