JSP191 Antibody Conditioning Regimen in MDS/AML Subjects Undergoing Allogenic Hematopoietic Stem Cell Transplantation
MYELODYSPLASTIC SYNDROME; MDS, ACUTE MYELOID LEUKEMIA; AML
About this trial
This is an interventional treatment trial for MYELODYSPLASTIC SYNDROME; MDS focused on measuring ACUTE MYELOID LEUKEMIA, AML, MDS, MYELODYSPLASTIC SYNDROME
Eligibility Criteria
Key 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
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
Sites / Locations
- City of Hope Comprehensive Cancer CenterRecruiting
- Stanford UniversityRecruiting
- Rush University Medical CenterRecruiting
- Oregon Health & Science UniversityRecruiting
- Huntsman Cancer Institute - University of UtahRecruiting
- Fred Hutchinson Cancer Research CenterRecruiting
Arms of the Study
Arm 1
Experimental
Blood Stem Cell Transplant w/ anti-CD117 conditioning
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.