Clinical trial NCT04429191: JSP191 Antibody Conditioning Regimen in MDS/AML Subjects Undergoing Allogenic Hematopoietic Stem Cell Transplantation
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: MYELODYSPLASTIC SYNDROME; MDS
ACUTE MYELOID LEUKEMIA; AML
Keywords: ACUTE MYELOID LEUKEMIA
AML
MDS
MYELODYSPLASTIC SYNDROME
Lead sponsor: Jasper Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

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 are 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.

Eligibility criteria: 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

Primary outcomes:
measure: The number of subjects experiencing adverse events and serious adverse events will be assessed.
timeFrame: Up to 1 year post Donor Cell Transplant (28 days dose limiting toxicity period)
measure: The number of dose limiting toxicities will be assessed.
timeFrame: Up to 1 year post Donor Cell Transplant (28 days dose limiting toxicity period)
measure: The type of dose limiting toxicities will be assessed.
timeFrame: Up to 1 year post Donor Cell Transplant (28 days dose limiting toxicity period)
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute - University of Utah
state: Utah
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Stanford University
name: Lori Muffly, MD,MS
role: PRINCIPAL_INVESTIGATOR
affiliation: City of Hope Medical Center
name: Andrew Artz, MD,MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Fred Hutchinson Cancer Center
name: Bart Scott, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Huntsman Cancer Institute/ University of Utah
name: Catherine Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Arpita Gandhi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush University Medical Center
name: Ankur Varma, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: