JSP191 Antibody Targeting Conditioning in MDS/AML Patients Undergoing Hematopoietic Cell Transplantation

  • STATUS
    Recruiting
  • days left to enroll
    3
  • participants needed
    12
  • sponsor
    Jasper Therapeutics, Inc.
Updated on 27 January 2021

Summary

This is a Phase 1 study to evaluate the safety and tolerability of an antibody conditioning regimen known as JSP191, in combination with low dose radiation and fludarabine, in patients with Myelodysplastic Syndrome or Acute Myeloid Leukemia undergoing blood stem cell transplantation

Description

This is a Phase 1 study to evaluate the safety and tolerability of an antibody conditioning regimen known as JSP191, in combination with low dose radiation and fludarabine, in patients with Myelodysplastic Syndrome or Acute Myeloid Leukemia undergoing blood stem cell transplantation.

Blood Stem Cell transplantation offers the only potentially curative therapy for many forms of Acute Myeloid Leukemia (AML) and for Myelodysplastic Syndrome (MDS). While standard of care conditioning regimens given prior to blood Stem Cell transplantation, such as standard TBI/Flu conditioning is well tolerated, they are associated with increased rates of relapse due to persistence of disease causing Hematopoietic Stem Cells and insufficient graft versus leukemia effect.

The biological conditioning regimen, JSP191, is an antibody that binds to CD117. CD117 is the receptor for Stem Cell Factor on blood forming cells. CD117 binding to Stem Cell Factor is critical for survival and maintenance of blood forming stem cells.

The binding of JSP191 to CD117 blocks CD117 from binding to Stem Cell Factor on blood forming stem cells. In the absence of CD117/Stem Cell Factor binding, hematopoietic stem cells that are currently occupying the bone marrow niches in MDS/AML patients are depleted.

This study will investigate the safety and tolerability of adding JSP191 (an anti-CD117 monoclonal antibody therapy) to standard TBI/Flu conditioning regimen in adults with AML and MDS undergoing hematopoietic stem cell transplant.

Details
Condition Myelodysplastic Syndrome MDS, ACUTE MYELOID LEUKEMIA; AML, ACUTE MYELOID LEUKEMIA; AML, ACUTE MYELOID LEUKEMIA; AML, ACUTE MYELOID LEUKEMIA; AML, ACUTE MYELOID LEUKEMIA; AML
Treatment Humanized anti-CD117 Monoclonal Antibody (JSP191)
Clinical Study IdentifierNCT04429191
SponsorJasper Therapeutics, Inc.
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Myelodysplastic Syndrome MDS or ACUTE MYELOID LEUKEMIA; AML?
Do you have any of these conditions: ACUTE MYELOID LEUKEMIA; AML or Myelodysplastic Syndrome MDS?
Do you have any of these conditions: ACUTE MYELOID LEUKEMIA; AML or Myelodysplastic Syndrome MDS?
AML/MDS as defined by specific criteria, including but not limited to the following
subtypes
AML in CR, Flt3+ MRD+
AML in CR, Flt3- MRD+
MDS < 5% BM blasts, MID/MRD+
MDS 5 - 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

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

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